Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants

NCT01318694 | Completed Phase 3 Results DMC

• 2 other identifiers: CDEB025A23012010-022867-37
• Study Type: interventional
• Target: 1,081
• Locations: 21 countries
• Sites: 146

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)

Conditions

Hepatitis C

Keywords

Chronic hepatitis C; Cyclophilin inhibitor

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)

  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.

  12 weeks after the end of treatment

Secondary Outcomes (11)

• Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)

  24 weeks after the end of treatment

• Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)

  after 4 weeks of treatment

• Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment

  after 12 weeks of treatment

• Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment

  after 12 weeks of treatment

• Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment

  after 12 weeks of treatment

Study Arms (4)

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

Drug: Alisporivir; Drug: Peginterferon alfa-2a; Drug: Ribavirin

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)

Drug: Alisporivir; Drug: Peginterferon alfa-2a; Drug: Ribavirin

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

Drug: Alisporivir; Drug: Peginterferon alfa-2a; Drug: Ribavirin

Treatment Arm D

ACTIVE COMPARATOR

ALV Placebo with PEG and RBV for 48 weeks

Drug: Peginterferon alfa-2a; Drug: Ribavirin; Drug: ALV Placebo

Interventions

Alisporivir DRUG

ALV 200 mg soft gel capsules administered orally

Also known as: DEB025, ALV

Treatment Arm A; Treatment Arm B; Treatment Arm C

Peginterferon alfa-2a DRUG

PEG 180 μg administered via subcutaneous (s.c.) injection once weekly

Also known as: Pegasys®, PEG

Treatment Arm A; Treatment Arm B; Treatment Arm C; Treatment Arm D

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

Also known as: Copegus®, RBV

Treatment Arm A; Treatment Arm B; Treatment Arm C; Treatment Arm D

ALV Placebo DRUG

ALV placebo soft gel capsules administered orally

Also known as: Placebo

Treatment Arm D

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Debiopharm International SA: lead

Study Sites (146)

Novartis Investigative Site

Beverly Hills, California, 90211, United States

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Novartis Investigative Site

Oakland, California, 94612, United States

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Novartis Investigative Site

San Diego, California, 92101, United States

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Novartis Investigative Site

San Diego, California, 92123, United States

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Novartis Investigative Site

San Diego, California, 92128, United States

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Novartis Investigative Site

Ventura, California, 93003, United States

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Novartis Investigative Site

Bradenton, Florida, 34209, United States

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Maitland, Florida, 32751, United States

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Tampa, Florida, 33607, United States

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Springfield, Illinois, 62703, United States

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Indianapolis, Indiana, 46237, United States

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Novartis Investigative Site

Shreveport, Louisiana, 71130-3932, United States

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Baltimore, Maryland, 21202, United States

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Novartis Investigative Site

Baltimore, Maryland, 21229, United States

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Minneapolis, Minnesota, 55404, United States

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Novartis Investigative Site

St Louis, Missouri, 63110, United States

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Novartis Investigative Site

St Louis, Missouri, 63128, United States

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Omaha, Nebraska, 68198, United States

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Novartis Investigative Site

Newark, New Jersey, 07102, United States

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Brooklyn, New York, 11230, United States

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Novartis Investigative Site

New York, New York, 10016, United States

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Novartis Investigative Site

New York, New York, 10021, United States

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Novartis Investigative Site

Charlotte, North Carolina, 28203, United States

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Novartis Investigative Site

Fayetteville, North Carolina, 28304, United States

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Novartis Investigative Site

Arlington, Texas, 76012, United States

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Novartis Investigative Site

Dallas, Texas, 75246-2096, United States

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Novartis Investigative Site

Dallas, Texas, 75390, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78215, United States

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Salt Lake City, Utah, 84124, United States

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Fairfax, Virginia, 22031, United States

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Newport News, Virginia, 23602, United States

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Buenos Aires, Buenos Aires, C1125ABE, Argentina

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Buenos Aires, Buenos Aires, C1405BCK, Argentina

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Córdoba, Córdoba Province, X5004BAL, Argentina

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Rosario, Santa Fe Province, S2000DSV, Argentina

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Rosario, Santa Fe Province, S2002KDS, Argentina

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Darlinghurst, New South Wales, 2010, Australia

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Kingswood, New South Wales, 2747, Australia

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Kogarah, New South Wales, 2217, Australia

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Westmead, New South Wales, 2145, Australia

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Greenslopes, Queensland, 4120, Australia

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Fitzroy, Victoria, 3065, Australia

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Brussels, 1070, Belgium

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Brussels, 1090, Belgium

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Novartis Investigative Site

Ghent, 9000, Belgium

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Novartis Investigative Site

Calgary, Alberta, T2N 4n1, Canada

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Vancouver, British Columbia, V5Z 1J4, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Vancouver, British Columbia, v6z 2k5, Canada

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Downsview, Ontario, M3N 2Z9, Canada

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London, Ontario, N6A 4G5, Canada

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Toronto, Ontario, M5G 2C4, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Clichy, 92110, France

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Grenoble, 38043, France

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Lyon, 69317, France

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Toulouse, 31059, France

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Villejuif, 94805, France

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Berlin, 10969, Germany

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Berlin, 13353, Germany

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Cologne, 50937, Germany

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Essen, 45147, Germany

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Frankfurt, 60590, Germany

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Freiburg im Breisgau, 79106, Germany

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Hamburg, 20099, Germany

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Hanover, 30625, Germany

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Kiel, 24146, Germany

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Leipzig, 04103, Germany

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Mainz, 55131, Germany

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Hong Kong, Hong Kong, Hong Kong

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Békéscsaba, H-5600, Hungary

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Budapest, 1083, Hungary

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Budapest, 1097, Hungary

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Budapest, 1126, Hungary

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Debrecen, 4032, Hungary

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Kaposvár, 7400, Hungary

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Pécs, 7624, Hungary

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Székesfehérvár, 8000, Hungary

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Bologna, BO, 40138, Italy

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Genova, GE, 16132, Italy

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Milan, MI, 20121, Italy

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Milan, MI, 20122, Italy

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Milan, MI, 20162, Italy

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Rozzano, MI, 20089, Italy

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Palermo, PA, 90127, Italy

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Padua, PD, 35128, Italy

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Pavia, PV, 27100, Italy

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Roma, RM, 00133, Italy

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Torino, TO, 10126, Italy

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Bologna, 40138, Italy

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Napoli, 80135, Italy

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Mexico City, Mexico City, 14000, Mexico

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Monterrey, Nuevo León, 64020, Mexico

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Bialystok, 15-540, Poland

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Bydgoszcz, 85-030, Poland

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Chorzów, 41-500, Poland

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Kielce, 25-317, Poland

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Lódz, 91-347, Poland

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San Juan, 00909, Puerto Rico

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Bucharest, District 1, 050524, Romania

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Bucharest, District 3, 030317, Romania

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Iași, Iaşi, 700506, Romania

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Iași, Jud. Iasi, 700111, Romania

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Bucharest, 020125, Romania

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Cluj-Napoca, 400006, Romania

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Craiova, 200515, Romania

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Moscow, 111123, Russia

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Moscow, 119333, Russia

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Moscow, 119992, Russia

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Moscow, 127473, Russia

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Saint Petersburg, 194044, Russia

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Novartis Investigative Site

Saint Petersburg, 197376, Russia

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Novartis Investigative Site

Busan, Busan, 602-739, South Korea

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Novartis Investigative Site

Yangsan, Gyeongsangnam-do, 626-770, South Korea

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Novartis Investigative Site

Seoul, Korea, 03722, South Korea

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Novartis Investigative Site

Seoul, Korea, 05505, South Korea

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Kyunggi, Kyeonggi, 463-712, South Korea

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Busan, 602-715, South Korea

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Incheon, 22332, South Korea

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Pusan, 614-735, South Korea

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Seville, Andalusia, 41014, Spain

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Barcelona, Catalonia, 08003, Spain

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Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

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Novartis Investigative Site

Madrid, Madrid, 28029, Spain

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Novartis Investigative Site

Majadahonda, Madrid, 28222, Spain

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Valencia, Valencia, 46014, Spain

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Novartis Investigative Site

Chiayi City, Taiwan, 600, Taiwan

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Novartis Investigative Site

Niaosong Township, Taiwan, 83301, Taiwan

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Novartis Investigative Site

Taichung, Taiwan, 40447, Taiwan

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Novartis Investigative Site

Taipei, Taiwan, 10002, Taiwan

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Novartis Investigative Site

Douliu, 640, Taiwan

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Novartis Investigative Site

Kaohsiung City, 807, Taiwan

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Novartis Investigative Site

Bangkok, 10330, Thailand

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Novartis Investigative Site

Bangkok, 10700, Thailand

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Novartis Investigative Site

Chiang Mai, 50200, Thailand

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Novartis Investigative Site

Khon Kaen, 40002, Thailand

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Novartis Investigative Site

Songkhla, 90110, Thailand

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Novartis Investigative Site

Birmingham, B15 2TT, United Kingdom

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Novartis Investigative Site

London, E1 1BB, United Kingdom

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Novartis Investigative Site

London, SE5 9RS, United Kingdom

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Novartis Investigative Site

London, W2 1NY, United Kingdom

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Newcastle upon Tyne, NE7 7DN, United Kingdom

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Nottingham, NG7 2UH, United Kingdom

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Hanoi, Vietnam

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Novartis Investigative Site

Ho Chi Minh City, Vietnam

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MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Interventions

alisporivir; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

In April 2012, ALV and placebo were discontinued in all participants. Participants remained on PEG and RBV treatment.

Results Point of Contact

• Title: Vice President Clinical Research & Development
• Organization: Debiopharm International S.A.

info-international@debiopharm.com

4121 321 01 11

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2011
• First Posted: March 18, 2011
• Study Start: March 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 30, 2016
• Results First Posted: September 30, 2016

Record last verified: 2016-08

Locations

US (32); IT (13); ME (2); BE (3); RU (6); PL (5); TW (6); GB (6); ES (6); VN (2); AU (6); HU (8); PR (1); HK (1); FR (5); KR (8); RO (7); TH (5); CA (8); AR (5); DE (11)