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Completed

NCT Number: NCT01318694

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

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)

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alisporivir

Drug

ALV 200 mg soft gel capsules administered orally

Other names: DEB025, ALV

Peginterferon alfa-2a

Drug

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

Other names: Pegasys®, PEG

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

Other names: Copegus®, RBV

ALV Placebo

Drug

ALV placebo soft gel capsules administered orally

Other names: Placebo

Primary outcomes

  1. 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

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

    Time frame: 24 weeks after the end of treatment

    SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.

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

    Time frame: after 4 weeks of treatment

    RVR4 was defined as serum HCV RNA < LOQ after 4 weeks of treatment.

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

    Time frame: after 12 weeks of treatment

    EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA < LOQ after 12 weeks of treatment.

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

    Time frame: after 12 weeks of treatment

    pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment.

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

    Time frame: after 12 weeks of treatment

    cEVR was defined as serum HCV RNA < LOQ after 12 weeks of treatment.

  6. 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

    eRVR was defined as achieving RVR4 and maintaining HCV RNA < LOQ until Week 12.

  7. Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks

    Time frame: at treatment end within 48 weeks

    ETR was defined as serum HCV RNA < LOQ at treatment end (completed or prematurely discontinued).

  8. Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks

    Time frame: within 48 weeks

    ALT abnormalities were summarized as participants who had either:

    • ALT > 2 x upper limit of normal (ULN) during the study and > 2 x ULN at baseline
    • ALT > 3 x ULN during the study and > 2 x ULN at baseline

  9. Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks

    Time frame: within 48 weeks

    Grading was according to the Modified Division of Microbiology & Infectious Diseases (DMID) Toxicity Tables (version 2.0).

    Participants with multiple abnormalities were counted only once in the worst category.

  10. Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks

    Time frame: within 48 weeks

    Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.

  11. Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks

    Time frame: within 48 weeks

    Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.

Sponsors and collaborators

Lead sponsor

Debiopharm International SA

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 18, 2011
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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