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Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1

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ClinicalTrials.gov Identifier: NCT01446250
Recruitment Status : Terminated
First Posted : October 5, 2011
Results First Posted : January 16, 2017
Last Update Posted : January 16, 2017
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 Hepatitis C
Interventions Drug: Alisporivir
Drug: Boceprevir
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Alisporivir Boceprevir PEGinf + RBV No Intervention
Hide Arm/Group Description Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1. Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2. Participants who received ALV in Treatment Period 1 were put on clinical hold but continued receiving PEGinf and RBV for 4 weeks, after which they switched to BOC triple therapy in Treatment Period 2. Participants who had an End of Treatment Response (ETR) were followed-up for 24 weeks after the last dose of BOC triple therapy (in Treatment Period 2) and participants who did not respond for any reason or discontinued the treatment early were followed-up for 12 weeks after the last dose of BOC (in Treatment Period 2).
Period Title: Treatment Period 1
Started 5 3 0 0
Completed 5 2 0 0
Not Completed 0 1 0 0
Period Title: Clinical Hold
Started 0 2 5 0
Completed 0 2 5 0
Not Completed 0 0 0 0
Period Title: Treatment Period 2
Started 0 7 0 0
Completed 0 6 0 0
Not Completed 0 1 0 0
Period Title: Follow-up
Started 0 0 0 6
Completed 0 0 0 0
Not Completed 0 0 0 6
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description Analysis was performed on all enrolled participants.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
5
  62.5%
Male
3
  37.5%
1.Primary Outcome
Title Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events
Hide Description [Not Specified]
Time Frame within 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.
Arm/Group Title Alisporivir Boceprevir
Hide Arm/Group Description:
Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Percentage of Participants With Emergence of Resistant Mutations
Hide Description [Not Specified]
Time Frame within 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.
Arm/Group Title Alisporivir Boceprevir
Hide Arm/Group Description:
Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24)
Hide Description SVR24 was defined as hepatitis C virus (HCV) RNA undetectable (by limit of detection) 24 weeks after end of treatment.
Time Frame 24 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.
Arm/Group Title Alisporivir Boceprevir
Hide Arm/Group Description:
Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alisporivir Boceprevir PEGinf + RBV No Intervention
Hide Arm/Group Description Adverse event (AE) occurred while taking Alisporivir + PEGinf + RBV. AE occurred while taking Boceprevir + PEGinf + RBV. AE occurred while taking only PEGinf + RBV. AE was discovered while taking no intervention.
All-Cause Mortality
Alisporivir Boceprevir PEGinf + RBV No Intervention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alisporivir Boceprevir PEGinf + RBV No Intervention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   1/8 (12.50%)   0/8 (0.00%)   0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Chronic Obstructive Pulmonary Disease  1  0/5 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alisporivir Boceprevir PEGinf + RBV No Intervention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/5 (100.00%)   8/8 (100.00%)   4/8 (50.00%)   1/6 (16.67%) 
Blood and lymphatic system disorders         
Anaemia  1  0/5 (0.00%)  3/8 (37.50%)  0/8 (0.00%)  0/6 (0.00%) 
Neutropenia  1  1/5 (20.00%)  1/8 (12.50%)  1/8 (12.50%)  0/6 (0.00%) 
Eye disorders         
Vision Blurred  1  1/5 (20.00%)  0/8 (0.00%)  0/8 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders         
Diarrhoea  1  1/5 (20.00%)  2/8 (25.00%)  2/8 (25.00%)  0/6 (0.00%) 
Gastric Ulcer  1  0/5 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/6 (16.67%) 
Vomiting  1  1/5 (20.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Nausea  1  1/5 (20.00%)  1/8 (12.50%)  2/8 (25.00%)  0/6 (0.00%) 
Dry Mouth  1  0/5 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/6 (0.00%) 
Abdominal Pain Upper  1  0/5 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
General disorders         
Fatigue  1  1/5 (20.00%)  2/8 (25.00%)  3/8 (37.50%)  0/6 (0.00%) 
Influenza Like Illness  1  1/5 (20.00%)  0/8 (0.00%)  0/8 (0.00%)  0/6 (0.00%) 
Pyrexia  1  1/5 (20.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Chest Discomfort  1  0/5 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/6 (0.00%) 
Pain  1  1/5 (20.00%)  1/8 (12.50%)  1/8 (12.50%)  0/6 (0.00%) 
Injection Site Erythema  1  0/5 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Non-Cardiac Chest Pain  1  0/5 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Irritability  1  0/5 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Immune system disorders         
Seasonal Allergy  1  0/5 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Infections and infestations         
Nasopharyngitis  1  0/5 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/6 (0.00%) 
Gastroenteritis Viral  1  0/5 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/6 (0.00%) 
Pharyngitis Streptococcal  1  0/5 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/6 (0.00%) 
Oral Candidiasis  1  0/5 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/6 (0.00%) 
Investigations         
Haematocrit Decreased  1  1/5 (20.00%)  1/8 (12.50%)  0/8 (0.00%)  0/6 (0.00%) 
Haemoglobin Decreased  1  1/5 (20.00%)  1/8 (12.50%)  0/8 (0.00%)  0/6 (0.00%) 
Blood Creatinine Increased  1  0/5 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Metabolism and nutrition disorders         
Decreased Appetite  1  1/5 (20.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Hypertriglyceridaemia  1  1/5 (20.00%)  0/8 (0.00%)  0/8 (0.00%)  0/6 (0.00%) 
Gout  1  0/5 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Nervous system disorders         
Headache  1  2/5 (40.00%)  2/8 (25.00%)  1/8 (12.50%)  0/6 (0.00%) 
Disturbance in Attention  1  1/5 (20.00%)  0/8 (0.00%)  0/8 (0.00%)  0/6 (0.00%) 
Dysgeusia  1  0/5 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/6 (0.00%) 
Dizziness  1  0/5 (0.00%)  1/8 (12.50%)  2/8 (25.00%)  0/6 (0.00%) 
Ageusia  1  0/5 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Memory Impairment  1  0/5 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Psychiatric disorders         
Sleep Disorder  1  0/5 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/6 (0.00%) 
Libido Decreased  1  0/5 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/6 (0.00%) 
Confusional State  1  0/5 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/5 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/6 (0.00%) 
Dyspnoea  1  0/5 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders         
Pruritus Generalised  1  1/5 (20.00%)  0/8 (0.00%)  0/8 (0.00%)  0/6 (0.00%) 
Rash Pruritic  1  2/5 (40.00%)  0/8 (0.00%)  0/8 (0.00%)  0/6 (0.00%) 
Rash  1  0/5 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/6 (0.00%) 
Vascular disorders         
Hot Flush  1  0/5 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Due to the early termination of study enrollment and discontinuation of alisporivir treatment, Amendment 1 changed the number of study arms to 2, combining Arms A and B, and none of the planned outcome measures could be evaluated.
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
Name/Title: Vice President Clinical Research & Development
Organization: Debiopharm International S.A.
Phone: 4121 321 01 11
Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT01446250     History of Changes
Other Study ID Numbers: CDEB025A2307
First Submitted: September 26, 2011
First Posted: October 5, 2011
Results First Submitted: June 10, 2016
Results First Posted: January 16, 2017
Last Update Posted: January 16, 2017