Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
- Conditions
- Chronic PainHepatitis C
- Interventions
- Registration Number
- NCT01215643
- Lead Sponsor
- Debiopharm International SA
- Brief Summary
The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 340
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ALV 1000 mg Alisporivir Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24. PEG+RBV Peginterferon alfa-2a Peginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24. ALV 600 mg+RBV Ribavirin Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24. ALV 800 mg+RBV Alisporivir Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg+RBV Alisporivir Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24. ALV 800 mg+RBV Ribavirin Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. ALV 600 mg+PEG Alisporivir Alisporivir (ALV) 600 mg BID with Peginterferon alfa-2a (PEG) for 1 week, followed by ALV 600 mg QD with PEG once weekly during Weeks 2 to 24. ALV 600 mg+PEG Peginterferon alfa-2a Alisporivir (ALV) 600 mg BID with Peginterferon alfa-2a (PEG) for 1 week, followed by ALV 600 mg QD with PEG once weekly during Weeks 2 to 24. PEG+RBV Ribavirin Peginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ) after 4 weeks of treatment RVR4LOQ was defined as RVR \[serum hepatitis C virus (HCV) ribonucleic acid (RNA) \< the limit of quantification (LOQ), i.e., \< 25 IU/mL\], after 4 weeks of treatment.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD) after 4 weeks of treatment RVR4LOD was defined as Rapid Viral Response (RVR) \[serum HCV RNA \< the limit of detection (LOD), i.e., \< 10 IU/mL\], after 4 weeks of treatment.
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2) after 4 weeks of treatment Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3) after 4 weeks of treatment Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD) after 12 weeks of treatment cEVR12LOQ and cEVR12LOD were defined as cEVR \[serum HCV RNA \< LOQ and \< LOD\] after 12 weeks of treatment, respectively.
Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD) at end of treatment, within 24 weeks ETR24LOQ and ETR24LOD were defined as ETR \[serum HCV RNA \< LOQ and \< LOD\] after 24 weeks of treatment or when prematurely discontinued.
Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD) 12 weeks after the end of treatment SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) \[serum HCV RNA \< LOQ and \< LOD\] 12 weeks after treatment, respectively.
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2) after 12 weeks of treatment Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3) after 12 weeks of treatment Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD) 24 weeks after the end of treatment Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2) 24 weeks after the end of treatment Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2) at end of treatment, within 24 weeks Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3) at end of treatment, within 24 weeks Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3) 12 weeks after the end of treatment Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2) 12 weeks after the end of treatment Percentage of Participants With On-treatment Viral Breakthrough within 24 weeks of treatment Viral breakthrough was defined as either:
* Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or
* HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (\< LOD) during treatmentPercentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3) 24 weeks after the end of treatment Percentage of Participants With Viral Relapse within 24 weeks after the end of treatment Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (\< LOD) during treatment.
Trial Locations
- Locations (22)
The North Texas Research Institute
🇺🇸Arlington, Texas, United States
Saint Louis University
🇺🇸St. Louis, Missouri, United States
Liver Associates of Texas
🇺🇸Houston, Texas, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Sharp Rees-Stealy Medical Group, Inc.
🇺🇸San Diego, California, United States
Island View Gastroenterology Associates
🇺🇸Ventura, California, United States
Research and Education Inc.
🇺🇸San Diego, California, United States
Hawai Medical Center East LLC
🇺🇸Honolulu, Hawaii, United States
Weill Cornell Medical Center
🇺🇸New York, New York, United States
The Office of Dr. Claudia Martorell
🇺🇸Springfield, Massachusetts, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Liver Specialist of Texas
🇺🇸Houston, Texas, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Novartis Investigative Site
🇬🇧Plymouth, United Kingdom
Novartis Korea Ltd.
🇰🇷Seoul, Korea, Republic of
Novartis Investigative Center
🇦🇺Greenslopes, Queensland, Australia
Novartis Inestigative Center
🇰🇷Pusan, Korea, Republic of
Cotton O'Neil Clinical Research
🇺🇸Topeka, Kansas, United States
Novartis Inestigative Site
🇮🇹Roma, Italy
Fundacion de Investigacion de Diego
🇵🇷San Juan, Puerto Rico
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States