Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00537407
Recruitment Status : Completed
First Posted : October 1, 2007
Results First Posted : May 7, 2015
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: Debio 025
Drug: Peg-IFNα2a
Drug: Ribavirin
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D Treatment Arm E
Hide Arm/Group Description

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Period Title: Part 1 Weeks 1-4
Started 10 9 11 10 10
Completed 10 9 11 10 10
Not Completed 0 0 0 0 0
Period Title: Part 2 Weeks 5-48 or 72
Started 10 9 11 10 10
Completed 2 1 2 4 3
Not Completed 8 8 9 6 7
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D Treatment Arm E Total
Hide Arm/Group Description

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Total of all reporting groups
Overall Number of Baseline Participants 10 9 11 10 10 50
Hide Baseline Analysis Population Description
Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 11 participants 10 participants 10 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
9
 100.0%
11
 100.0%
10
 100.0%
10
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 9 participants 11 participants 10 participants 10 participants 50 participants
51.4  (6.62) 52.6  (5.94) 49.9  (10.71) 48.5  (9.87) 52.8  (6.51) 51.0  (8.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 11 participants 10 participants 10 participants 50 participants
Female
3
  30.0%
5
  55.6%
5
  45.5%
5
  50.0%
3
  30.0%
21
  42.0%
Male
7
  70.0%
4
  44.4%
6
  54.5%
5
  50.0%
7
  70.0%
29
  58.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 9 participants 11 participants 10 participants 10 participants 50 participants
10 9 11 10 10 50
1.Primary Outcome
Title Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Triple Therapy Treatment Arms (A, D, and E)
Hide Description Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.
Time Frame Baseline to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.
Arm/Group Title Treatment Arm A Treatment Arm D Treatment Arm E
Hide Arm/Group Description:

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Overall Number of Participants Analyzed 10 10 10
Mean (Standard Deviation)
Unit of Measure: Log10(IU/mL)
-0.881  (1.0099) -2.321  (1.4644) -2.020  (1.4031)
2.Secondary Outcome
Title Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Monotherapy and Dual Therapy Treatment Arms (B and C)
Hide Description Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.
Time Frame Baseline to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.
Arm/Group Title Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: Log10(IU/mL)
0.285  (0.3273) -0.608  (0.7558)
3.Secondary Outcome
Title log10 Hepatitis C Virus RNA at Day 29
Hide Description Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D Treatment Arm E
Hide Arm/Group Description:

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Overall Number of Participants Analyzed 10 9 11 10 10
Mean (Standard Deviation)
Unit of Measure: Log10(IU/mL)
5.567  (1.0165) 6.662  (0.3295) 5.827  (0.7270) 4.000  (1.4325) 4.245  (1.6337)
4.Secondary Outcome
Title Percentage of Participants With a Rapid Viral Response at Day 29
Hide Description A participant had a rapid viral response if their viral RNA was undetectable (< 10 IU/mL).
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D Treatment Arm E
Hide Arm/Group Description:

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Overall Number of Participants Analyzed 10 9 11 10 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 30.8)
0.0
(0.0 to 33.6)
0.0
(0.0 to 28.5)
10
(0.3 to 44.5)
10
(0.3 to 44.5)
5.Secondary Outcome
Title Percentage of Participants With an Early Viral Response at Week 12
Hide Description A participant had an early viral response if their viral RNA had decreased ≥ 2 log10 at Week 12 compared to Baseline.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D Treatment Arm E
Hide Arm/Group Description:

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Overall Number of Participants Analyzed 10 9 11 10 10
Measure Type: Number
Unit of Measure: percentage of participants
30.0 11.1 27.3 70.0 30.0
6.Secondary Outcome
Title Percentage of Participants With an End-of-treatment Response at the End of Treatment (Week 48 or 72)
Hide Description A participant had an end-of-treatment response if their viral RNA was undetectable (< 10 IU/mL).
Time Frame End of treatment (Week 48 or 72)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D Treatment Arm E
Hide Arm/Group Description:

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Overall Number of Participants Analyzed 10 9 11 10 10
Measure Type: Number
Unit of Measure: percentage of participants
20.0 11.1 18.2 10.0 30.0
7.Secondary Outcome
Title Percentage of Participants With a Sustained Viral Response 24 Weeks After the End of Treatment (Week 72 or 96)
Hide Description A participant had a sustained viral response if their viral RNA was undetectable (< 10 IU/mL).
Time Frame 24 weeks after the end of treatment (Week 72 or 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D Treatment Arm E
Hide Arm/Group Description:

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Overall Number of Participants Analyzed 10 9 11 10 10
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 9.1 0.0 10.0
Time Frame Within 72 weeks
Adverse Event Reporting Description Safety population: All participants who received any dose of Debio 025 and had at least 1 post-baseline assessment.
 
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D Treatment Arm E
Hide Arm/Group Description

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response

Debio 025: Debio 025 supplied as a 100 mg/mL oral solution

Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

Ribavirin: Ribavirin supplied as 200 mg tablets

All-Cause Mortality
Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D Treatment Arm E
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D Treatment Arm E
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/9 (0.00%)      1/11 (9.09%)      0/10 (0.00%)      0/10 (0.00%)    
Infections and infestations           
Acute Pyelonephritis  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Arm A Treatment Arm B Treatment Arm C Treatment Arm D Treatment Arm E
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      9/9 (100.00%)      11/11 (100.00%)      10/10 (100.00%)      10/10 (100.00%)    
Blood and lymphatic system disorders           
Anaemia  1  4/10 (40.00%)  5 0/9 (0.00%)  0 1/11 (9.09%)  1 2/10 (20.00%)  2 2/10 (20.00%)  2
Leukopenia  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 2/10 (20.00%)  2
Lymphadenopathy  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Neutropenia  1  5/10 (50.00%)  5 1/9 (11.11%)  1 4/11 (36.36%)  4 1/10 (10.00%)  1 4/10 (40.00%)  6
Thrombocytopenia  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 2/10 (20.00%)  2
Endocrine disorders           
Hypothyroidism  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Eye disorders           
Diplopia  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Dry Eye  1  0/10 (0.00%)  0 1/9 (11.11%)  1 1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Foreign body sensation in eyes  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Photophobia  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Vision Blurred  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Gastrointestinal disorders           
Abdominal Distension  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Abdominal Pain  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Abdominal Pain Upper  1  0/10 (0.00%)  0 2/9 (22.22%)  2 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Aphthous Stomatitis  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Chapped lips  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Constipation  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  2 0/10 (0.00%)  0
Diarrhoea  1  1/10 (10.00%)  1 1/9 (11.11%)  1 1/11 (9.09%)  1 0/10 (0.00%)  0 2/10 (20.00%)  2
Dyspepsia  1  0/10 (0.00%)  0 1/9 (11.11%)  1 1/11 (9.09%)  1 0/10 (0.00%)  0 1/10 (10.00%)  1
Faecal Volume Increased  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Faeces Pale  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Flatulence  1  2/10 (20.00%)  2 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Gastrooesophageal reflux disease  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0
Gingival pain  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Gingivitis  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Hunger  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Nausea  1  3/10 (30.00%)  4 1/9 (11.11%)  1 2/11 (18.18%)  3 3/10 (30.00%)  3 3/10 (30.00%)  5
Salivary Hypersecretion  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Sensitivity of Teeth  1  0/10 (0.00%)  0 1/9 (11.11%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Stomatitis  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Tooth disorder  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Vomiting  1  0/10 (0.00%)  0 1/9 (11.11%)  1 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
General disorders           
Asthenia  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Chest Discomfort  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  2 0/10 (0.00%)  0
Chills  1  3/10 (30.00%)  3 1/9 (11.11%)  1 1/11 (9.09%)  1 0/10 (0.00%)  0 2/10 (20.00%)  2
Early Satiety  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Face oedema  1  0/10 (0.00%)  0 1/9 (11.11%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Fatigue  1  4/10 (40.00%)  5 2/9 (22.22%)  2 4/11 (36.36%)  4 5/10 (50.00%)  5 8/10 (80.00%)  10
Influenza Like Illness  1  1/10 (10.00%)  1 1/9 (11.11%)  1 1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Injection Site Erythema  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 2/10 (20.00%)  2
Injection Site Haematoma  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Injection Site Reaction  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  1 2/10 (20.00%)  2
Irritability  1  1/10 (10.00%)  1 1/9 (11.11%)  1 3/11 (27.27%)  3 2/10 (20.00%)  2 2/10 (20.00%)  2
Local swelling  1  0/10 (0.00%)  0 1/9 (11.11%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Malaise  1  2/10 (20.00%)  2 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Pain  1  3/10 (30.00%)  3 0/9 (0.00%)  0 1/11 (9.09%)  3 0/10 (0.00%)  0 0/10 (0.00%)  0
Pyrexia  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  3 3/10 (30.00%)  5
Thirst  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Hepatobiliary disorders           
Hyperbilirubinaemia  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Jaundice  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Infections and infestations           
Dermatitis infected  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Nail bed infection  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Nasopharyngitis  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Oral Herpes  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Pharyngitis streptococcal  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Pilonidal cyst  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Pyelonephritis acute  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Tonsillitis  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Tooth abscess  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Upper Respiratory Tract Infection  1  0/10 (0.00%)  0 1/9 (11.11%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Urinary tract infection  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Injury, poisoning and procedural complications           
Contusion  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1
Skin Laceration  1  0/10 (0.00%)  0 1/9 (11.11%)  2 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Tendon rupture  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Investigations           
Alanine Aminotransferase Increased  1  1/10 (10.00%)  1 0/9 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0
Aspartate Aminotransferase Increased  1  1/10 (10.00%)  1 0/9 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0
Bacteria urine  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Blood Bilirubin Increased  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Blood Lactate Dehydrogenase Increased  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Blood Thyroid Stimulating Hormone Increased  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  2 0/10 (0.00%)  0 1/10 (10.00%)  1
Blood Triglycerides Increased  1  1/10 (10.00%)  1 1/9 (11.11%)  1 1/11 (9.09%)  1 2/10 (20.00%)  2 1/10 (10.00%)  1
Blood glucose increased  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Blood phosphorus decreased  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Blood pressure increased  1  0/10 (0.00%)  0 1/9 (11.11%)  1 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Gamma-glutamyltransferase Increased  1  1/10 (10.00%)  2 0/9 (0.00%)  0 2/11 (18.18%)  2 1/10 (10.00%)  1 0/10 (0.00%)  0
Haematocrit decreased  1  0/10 (0.00%)  0 1/9 (11.11%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Haemoglobin decreased  1  0/10 (0.00%)  0 1/9 (11.11%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Lymphocyte count decreased  1  0/10 (0.00%)  0 1/9 (11.11%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Mean cell volume increased  1  0/10 (0.00%)  0 1/9 (11.11%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Neutrophil Count Decreased  1  1/10 (10.00%)  1 1/9 (11.11%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Neutrophil count increased  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Osteocalcin Increased  1  1/10 (10.00%)  1 1/9 (11.11%)  1 1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Platelet Count Decreased  1  1/10 (10.00%)  1 1/9 (11.11%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Red blood cells urine  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Urine Output Increased  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Weight decreased  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 1/10 (10.00%)  1
White blood cell count decreased  1  0/10 (0.00%)  0 1/9 (11.11%)  1 1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
White blood cell count increased  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Metabolism and nutrition disorders           
Decreased Appetite  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1
Gout  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Hyperglycaemia  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Hypertriglyceridaemia  1  0/10 (0.00%)  0 1/9 (11.11%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Arthralgia  1  1/10 (10.00%)  1 1/9 (11.11%)  1 3/11 (27.27%)  3 1/10 (10.00%)  1 2/10 (20.00%)  2
Back Pain  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Flank pain  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Myalgia  1  1/10 (10.00%)  1 1/9 (11.11%)  1 4/11 (36.36%)  4 2/10 (20.00%)  2 0/10 (0.00%)  0
Osteopenia  1  1/10 (10.00%)  1 1/9 (11.11%)  1 0/11 (0.00%)  0 1/10 (10.00%)  1 2/10 (20.00%)  2
Resorption Bone Increased  1  1/10 (10.00%)  1 1/9 (11.11%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Nervous system disorders           
Dizziness  1  0/10 (0.00%)  0 1/9 (11.11%)  1 2/11 (18.18%)  2 1/10 (10.00%)  1 0/10 (0.00%)  0
Headache  1  3/10 (30.00%)  4 2/9 (22.22%)  2 2/11 (18.18%)  2 6/10 (60.00%)  8 3/10 (30.00%)  4
Hypoaesthesia  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Mental Impairment  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Parosmia  1  0/10 (0.00%)  0 1/9 (11.11%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Psychomotor Hyperactivity  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Psychiatric disorders           
Agitation  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Anxiety  1  0/10 (0.00%)  0 0/9 (0.00%)  0 3/11 (27.27%)  3 0/10 (0.00%)  0 1/10 (10.00%)  1
Depressed Mood  1  1/10 (10.00%)  1 0/9 (0.00%)  0 1/11 (9.09%)  1 2/10 (20.00%)  2 0/10 (0.00%)  0
Depression  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1
Insomnia  1  2/10 (20.00%)  2 2/9 (22.22%)  2 4/11 (36.36%)  4 5/10 (50.00%)  5 0/10 (0.00%)  0
Memory impairment  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Renal and urinary disorders           
Chromaturia  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 2/10 (20.00%)  2 2/10 (20.00%)  2
Glycosurea  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  2 0/10 (0.00%)  0
Haematuria  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Pollakiuria  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 2/10 (20.00%)  2 2/10 (20.00%)  3
Proteinuria  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Reproductive system and breast disorders           
Menstruation Irregular  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Cough  1  1/10 (10.00%)  1 0/9 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  1 1/10 (10.00%)  1
Dry throat  1  0/10 (0.00%)  0 1/9 (11.11%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Dyspneoa  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Dyspnoea Exertional  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Increased bronchial secretion  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Nasal Dryness  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Nasal congestion  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Oropharyngeal Pain  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0
Paranasal sinus hypersecretion  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Rales  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Rhinorrhoea  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Wheezing  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders           
Alopecia  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1
Dry skin  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  2 1/10 (10.00%)  1
Erythema  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Hyperhidrosis  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Night Sweats  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Pruritus  1  0/10 (0.00%)  0 2/9 (22.22%)  2 1/11 (9.09%)  1 1/10 (10.00%)  1 2/10 (20.00%)  3
Pruritus Generalised  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Psoriasis  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Rash  1  2/10 (20.00%)  2 2/9 (22.22%)  2 0/11 (0.00%)  0 1/10 (10.00%)  2 2/10 (20.00%)  2
Rash Macular  1  0/10 (0.00%)  0 1/9 (11.11%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Rash Maculo-papular  1  0/10 (0.00%)  0 0/9 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 1/10 (10.00%)  1
Rash vesicular  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Seborrhoeic Dermatitis  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1
Skin Odour Abnormal  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Skin lesion  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Vascular disorders           
Hot Flush  1  0/10 (0.00%)  0 1/9 (11.11%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Hypertension  1  1/10 (10.00%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0 2/10 (20.00%)  2 0/10 (0.00%)  0
Venous insufficiency  1  0/10 (0.00%)  0 0/9 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jean-Maurice Dumont, Vice President Medical Affairs
Organization: Debiopharm International S.A.
Phone: 4121 321 01 11
EMail: jean-maurice.dumont@debiopharm.com
Layout table for additonal information
Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT00537407     History of Changes
Other Study ID Numbers: Debio 025-HCV-207
DEB025A2207 ( Other Identifier: Sponsor Code )
First Submitted: September 28, 2007
First Posted: October 1, 2007
Results First Submitted: April 1, 2015
Results First Posted: May 7, 2015
Last Update Posted: February 17, 2016