--- title: Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants nct_id: NCT01318694 overall_status: COMPLETED phase: PHASE3 sponsor: Debiopharm International SA study_type: INTERVENTIONAL primary_condition: Hepatitis C countries: United States, Argentina, Australia, Belgium, Canada, France, Germany, Hong Kong, Hungary, Italy, Mexico, Poland, Puerto Rico, Romania, Russia, South Korea, Spain, Taiwan, Thailand, United Kingdom, Vietnam canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01318694.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01318694" ct_last_update_post_date: 2016-09-30 last_seen_at: "2026-05-12T06:22:02.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants **Official Title:** A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFNα2a and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve Patients **NCT ID:** [NCT01318694](https://clinicaltrials.gov/study/NCT01318694) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 1081 - **Lead Sponsor:** Debiopharm International SA - **Conditions:** Hepatitis C - **Start Date:** 2011-03 - **Completion Date:** 2013-08 - **CT.gov Last Update:** 2016-09-30 ## Brief Summary This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy \[i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)\] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1) ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 70 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion criteria: * Chronic HCV infection * HCV genotype 1 * No previous treatment for hepatitis C infection * Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit * Liver evaluation prior to baseline: liver biopsy within 3 years or Fibroscan within 6 months Exclusion criteria: * HCV genotype different from genotype 1 or co-infection with other HCV genotype * Co-infection with Hepatitis B or HIV * Any other cause of relevant liver disease other than HCV * Presence or history of hepatic decompensation * Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN), more than 1 episode of elevated bilirubin (\> ULN) in past 6 months Other protocol-defined inclusion/exclusion criteria may apply. ``` ## Arms - **Treatment Arm A** (EXPERIMENTAL) — Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT): * Participants with a viral load below the level of detection (\< LOD) at Week 4 stop study treatment after 24 weeks * Participants with a viral load ≥ LOD at Week 4 complete 48 weeks of study treatment - **Treatment Arm B** (EXPERIMENTAL) — Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT) - **Treatment Arm C** (EXPERIMENTAL) — Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks - **Treatment Arm D** (ACTIVE_COMPARATOR) — ALV Placebo with PEG and RBV for 48 weeks ## Interventions - **Alisporivir** (DRUG) — ALV 200 mg soft gel capsules administered orally - **Peginterferon alfa-2a** (DRUG) — PEG 180 μg administered via subcutaneous (s.c.) injection once weekly - **Ribavirin** (DRUG) — RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose - **ALV Placebo** (DRUG) — ALV placebo soft gel capsules administered orally ## Primary Outcomes - **Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)** _(time frame: 12 weeks after the end of treatment)_ — SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (\< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment. ## Secondary Outcomes - **Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)** _(time frame: 24 weeks after the end of treatment)_ - **Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)** _(time frame: after 4 weeks of treatment)_ - **Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment** _(time frame: after 12 weeks of treatment)_ - **Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment** _(time frame: after 12 weeks of treatment)_ - **Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment** _(time frame: after 12 weeks of treatment)_ - **Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment** _(time frame: from 4 to 12 weeks of treatment)_ - **Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks** _(time frame: at treatment end within 48 weeks)_ - **Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks** _(time frame: within 48 weeks)_ - **Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks** _(time frame: within 48 weeks)_ - **Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks** _(time frame: within 48 weeks)_ - **Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks** _(time frame: within 48 weeks)_ ## Locations (146) - Novartis Investigative Site, Beverly Hills, California, United States - Novartis Investigative Site, Oakland, California, United States - Novartis Investigative Site, San Diego, California, United States - Novartis Investigative Site, San Diego, California, United States - Novartis Investigative Site, San Diego, California, United States - Novartis Investigative Site, Ventura, California, United States - Novartis Investigative Site, Bradenton, Florida, United States - Novartis Investigative Site, Maitland, Florida, United States - Novartis Investigative Site, Tampa, Florida, United States - Novartis Investigative Site, Springfield, Illinois, United States - Novartis Investigative Site, Indianapolis, Indiana, United States - Novartis Investigative Site, Shreveport, Louisiana, United States - Novartis Investigative Site, Baltimore, Maryland, United States - Novartis Investigative Site, Baltimore, Maryland, United States - Novartis Investigative Site, Minneapolis, Minnesota, United States - Novartis Investigative Site, St Louis, Missouri, United States - Novartis Investigative Site, St Louis, Missouri, United States - Novartis Investigative Site, Omaha, Nebraska, United States - Novartis Investigative Site, Newark, New Jersey, United States - Novartis Investigative Site, Brooklyn, New York, United States - Novartis Investigative Site, New York, New York, United States - Novartis Investigative Site, New York, New York, United States - Novartis Investigative Site, Charlotte, North Carolina, United States - Novartis Investigative Site, Fayetteville, North Carolina, United States - Novartis Investigative Site, Arlington, Texas, United States - Novartis Investigative Site, Dallas, Texas, United States - Novartis Investigative Site, Dallas, Texas, United States - Novartis Investigative Site, Houston, Texas, United States - Novartis Investigative Site, San Antonio, Texas, United States - Novartis Investigative Site, Salt Lake City, Utah, United States - Novartis Investigative Site, Fairfax, Virginia, United States - Novartis Investigative Site, Newport News, Virginia, United States - Novartis Investigative Site, Buenos Aires, Buenos Aires, Argentina - Novartis Investigative Site, Buenos Aires, Buenos Aires, Argentina - Novartis Investigative Site, Córdoba, Córdoba Province, Argentina - Novartis Investigative Site, Rosario, Santa Fe Province, Argentina - Novartis Investigative Site, Rosario, Santa Fe Province, Argentina - Novartis Investigative Site, Darlinghurst, New South Wales, Australia - Novartis Investigative Site, Kingswood, New South Wales, Australia - Novartis Investigative Site, Kogarah, New South Wales, Australia - Novartis Investigative Site, Westmead, New South Wales, Australia - Novartis Investigative Site, Greenslopes, Queensland, Australia - Novartis Investigative Site, Fitzroy, Victoria, Australia - Novartis Investigative Site, Brussels, Belgium - Novartis Investigative Site, Brussels, Belgium - Novartis Investigative Site, Ghent, Belgium - Novartis Investigative Site, Calgary, Alberta, Canada - Novartis Investigative Site, Vancouver, British Columbia, Canada - Novartis Investigative Site, Vancouver, British Columbia, Canada - Novartis Investigative Site, Vancouver, British Columbia, Canada - Novartis Investigative Site, Downsview, Ontario, Canada - Novartis Investigative Site, London, Ontario, Canada - Novartis Investigative Site, Toronto, Ontario, Canada - Novartis Investigative Site, Toronto, Ontario, Canada - Novartis Investigative Site, Clichy, France - Novartis Investigative Site, Grenoble, France - Novartis Investigative Site, Lyon, France - Novartis Investigative Site, Toulouse, France - Novartis Investigative Site, Villejuif, France - Novartis Investigative Site, Berlin, Germany - Novartis Investigative Site, Berlin, Germany - Novartis Investigative Site, Cologne, Germany - Novartis Investigative Site, Essen, Germany - Novartis Investigative Site, Frankfurt, Germany - Novartis Investigative Site, Freiburg im Breisgau, Germany - Novartis Investigative Site, Hamburg, Germany - Novartis Investigative Site, Hanover, Germany - Novartis Investigative Site, Kiel, Germany - Novartis Investigative Site, Leipzig, Germany - Novartis Investigative Site, Mainz, Germany - Novartis Investigative Site, Hong Kong, Hong Kong, Hong Kong - Novartis Investigative Site, Békéscsaba, Hungary - Novartis Investigative Site, Budapest, Hungary - Novartis Investigative Site, Budapest, Hungary - Novartis Investigative Site, Budapest, Hungary - Novartis Investigative Site, Debrecen, Hungary - Novartis Investigative Site, Kaposvár, Hungary - Novartis Investigative Site, Pécs, Hungary - Novartis Investigative Site, Székesfehérvár, Hungary - Novartis Investigative Site, Bologna, BO, Italy - Novartis Investigative Site, Genova, GE, Italy - Novartis Investigative Site, Milan, MI, Italy - Novartis Investigative Site, Milan, MI, Italy - Novartis Investigative Site, Milan, MI, Italy - Novartis Investigative Site, Rozzano, MI, Italy - Novartis Investigative Site, Palermo, PA, Italy - Novartis Investigative Site, Padova, PD, Italy - Novartis Investigative Site, Pavia, PV, Italy - Novartis Investigative Site, Roma, RM, Italy - Novartis Investigative Site, Torino, TO, Italy - Novartis Investigative Site, Bologna, Italy - Novartis Investigative Site, Naples, Italy - Novartis Investigative Site, Mexico City, Mexico City, Mexico - Novartis Investigative Site, Monterrey, Nuevo León, Mexico - Novartis Investigative Site, Bialystok, Poland - Novartis Investigative Site, Bydgoszcz, Poland - Novartis Investigative Site, Chorzów, Poland - Novartis Investigative Site, Kielce, Poland - Novartis Investigative Site, Lódz, Poland - Novartis Investigative Site, San Juan, Puerto Rico - Novartis Investigative Site, Bucharest, District 1, Romania - Novartis Investigative Site, Bucharest, District 3, Romania - Novartis Investigative Site, Iași, Iaşi, Romania - Novartis Investigative Site, Iași, Jud. Iasi, Romania - Novartis Investigative Site, Bucharest, Romania - Novartis Investigative Site, Cluj-Napoca, Romania - Novartis Investigative Site, Craiova, Romania - Novartis Investigative Site, Moscow, Russia - Novartis Investigative Site, Moscow, Russia - Novartis Investigative Site, Moscow, Russia - Novartis Investigative Site, Moscow, Russia - Novartis Investigative Site, Saint Petersburg, Russia - Novartis Investigative Site, Saint Petersburg, Russia - Novartis Investigative Site, Busan, Busan, South Korea - Novartis Investigative Site, Yangsan, Gyeongsangnam-do, South Korea - Novartis Investigative Site, Seoul, Korea, South Korea - Novartis Investigative Site, Seoul, Korea, South Korea - Novartis Investigative Site, Kyunggi, Kyeonggi, South Korea - Novartis Investigative Site, Busan, South Korea - Novartis Investigative Site, Incheon, South Korea - Novartis Investigative Site, Pusan, South Korea - Novartis Investigative Site, Seville, Andalusia, Spain - Novartis Investigative Site, Barcelona, Catalonia, Spain - Novartis Investigative Site, Barcelona, Catalonia, Spain - Novartis Investigative Site, Madrid, Madrid, Spain - Novartis Investigative Site, Majadahonda, Madrid, Spain - Novartis Investigative Site, Valencia, Valencia, Spain - Novartis Investigative Site, Chiayi City, Taiwan, Taiwan - Novartis Investigative Site, Niaosong Township, Taiwan, Taiwan - Novartis Investigative Site, Taichung, Taiwan, Taiwan - Novartis Investigative Site, Taipei, Taiwan, Taiwan - Novartis Investigative Site, Douliu, Taiwan - Novartis Investigative Site, Kaohsiung City, Taiwan - Novartis Investigative Site, Bangkok, Thailand - Novartis Investigative Site, Bangkok, Thailand - Novartis Investigative Site, Chiang Mai, Thailand - Novartis Investigative Site, Khon Kaen, Thailand - Novartis Investigative Site, Songkhla, Thailand - Novartis Investigative Site, Birmingham, United Kingdom - Novartis Investigative Site, London, United Kingdom - Novartis Investigative Site, London, United Kingdom - Novartis Investigative Site, London, United Kingdom - Novartis Investigative Site, Newcastle upon Tyne, United Kingdom - Novartis Investigative Site, Nottingham, United Kingdom - Novartis Investigative Site, Hanoi, Vietnam - Novartis Investigative Site, Ho Chi Minh City, Vietnam ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - 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`locations.novartis investigative site|greenslopes|queensland|australia` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01318694.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01318694* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*