Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C

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: NCT01500772
Recruitment Status : Terminated
First Posted : December 28, 2011
Results First Posted : June 27, 2016
Last Update Posted : August 1, 2016
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Alisporivir
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Alisporivir
Hide Arm/Group Description Alisporivir (ALV) 400 mg twice daily (BID), with peginterferon alfa-2a (PEG) and ribavirin (RBV) for 48 weeks.
Period Title: Overall Study
Started 6
Completed 0
Not Completed 6
Arm/Group Title Alisporivir
Hide Arm/Group Description ALV 400 mg BID with PEG and RBV for 48 weeks.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
All enrolled patients
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
3
  50.0%
Male
3
  50.0%
1.Primary Outcome
Title Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)
Hide Description SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment.
Time Frame 12 weeks posttreatment
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated before the outcome measure time point.
Arm/Group Title Alisporivir
Hide Arm/Group Description:
ALV 400 mg BID with PEG and RBV for 48 weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)
Hide Description SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.
Time Frame 24 weeks posttreatment
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated before the outcome measure time point.
Arm/Group Title Alisporivir
Hide Arm/Group Description:
ALV 400 mg BID with PEG and RBV for 48 weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD)
Hide Description Level of detection (LOD) was defined as 10 IU/mL
Time Frame 12 weeks posttreatment
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated before the outcome measure time point.
Arm/Group Title Alisporivir
Hide Arm/Group Description:
ALV 400 mg BID with PEG and RBV for 48 weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated before the outcome measure time point.
Arm/Group Title Alisporivir
Hide Arm/Group Description:
ALV 400 mg BID with PEG and RBV for 48 weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline to end of treatment (maximum exposure: 25 days) plus 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alisporivir
Hide Arm/Group Description ALV 400 mg BID with PEG and RBV for 48 weeks.
All-Cause Mortality
Alisporivir
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alisporivir
Affected / at Risk (%)
Total   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alisporivir
Affected / at Risk (%)
Total   5/6 (83.33%) 
Blood and lymphatic system disorders   
Thrombocytopenia  1  2/6 (33.33%) 
Neutropenia  1  1/6 (16.67%) 
Gastrointestinal disorders   
Nausea  1  2/6 (33.33%) 
General disorders   
Pyrexia  1  3/6 (50.00%) 
Fatigue  1  1/6 (16.67%) 
Chills  1  1/6 (16.67%) 
Asthenia  1  1/6 (16.67%) 
Infections and infestations   
Nasopharyngitis  1  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/6 (16.67%) 
Bone Pain  1  1/6 (16.67%) 
Myalgia  1  1/6 (16.67%) 
Nervous system disorders   
Headache  1  4/6 (66.67%) 
Psychiatric disorders   
Sleep Disorder  1  1/6 (16.67%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  1/6 (16.67%) 
Dry Skin  1  1/6 (16.67%) 
Rash Pruritic  1  2/6 (33.33%) 
Skin Fissures  1  1/6 (16.67%) 
Seborrhoeic Dermatitis  1  1/6 (16.67%) 
Vascular disorders   
Hypertension  1  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Due to early termination of the study, 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 and Development
Organization: Debiopharm International S.A.
Phone: 4121 321 01 11
Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT01500772     History of Changes
Other Study ID Numbers: CDEB025A2306
2011-004653-31 ( EudraCT Number )
First Submitted: December 23, 2011
First Posted: December 28, 2011
Results First Submitted: May 19, 2016
Results First Posted: June 27, 2016
Last Update Posted: August 1, 2016