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Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants

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ClinicalTrials.gov Identifier: NCT01215643
Recruitment Status : Completed
First Posted : October 6, 2010
Results First Posted : August 30, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Chronic Pain Drug: Alisporivir Drug: Peginterferon alfa-2a Drug: Ribavirin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients
Study Start Date : October 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALV 1000 mg
Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.
Drug: Alisporivir
ALV 200 mg soft gel capsules administered orally
Other Names:
  • DEB025
  • ALV

Experimental: ALV 600 mg+RBV
Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24.
Drug: Alisporivir
ALV 200 mg soft gel capsules administered orally
Other Names:
  • DEB025
  • ALV

Drug: Ribavirin
RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
Other Names:
  • Copegus®
  • RBV

Experimental: ALV 800 mg+RBV
Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
Drug: Alisporivir
ALV 200 mg soft gel capsules administered orally
Other Names:
  • DEB025
  • ALV

Drug: Ribavirin
RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
Other Names:
  • Copegus®
  • RBV

Experimental: ALV 600 mg+PEG
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.
Drug: Alisporivir
ALV 200 mg soft gel capsules administered orally
Other Names:
  • DEB025
  • ALV

Drug: Peginterferon alfa-2a
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Other Names:
  • Pegasys®
  • PEG

Active Comparator: PEG+RBV
Peginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24.
Drug: Peginterferon alfa-2a
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Other Names:
  • Pegasys®
  • PEG

Drug: Ribavirin
RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
Other Names:
  • Copegus®
  • RBV




Primary Outcome Measures :
  1. Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ) [ Time Frame: 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 :
  1. Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD) [ Time Frame: 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.

  2. Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2) [ Time Frame: after 4 weeks of treatment ]
  3. Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3) [ Time Frame: after 4 weeks of treatment ]
  4. Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD) [ Time Frame: after 12 weeks of treatment ]
    cEVR12LOQ and cEVR12LOD were defined as cEVR [serum HCV RNA < LOQ and < LOD] after 12 weeks of treatment, respectively.

  5. Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2) [ Time Frame: after 12 weeks of treatment ]
  6. Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3) [ Time Frame: after 12 weeks of treatment ]
  7. Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD) [ Time Frame: 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.

  8. Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2) [ Time Frame: at end of treatment, within 24 weeks ]
  9. Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3) [ Time Frame: at end of treatment, within 24 weeks ]
  10. Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD) [ Time Frame: 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.

  11. Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2) [ Time Frame: 12 weeks after the end of treatment ]
  12. Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3) [ Time Frame: 12 weeks after the end of treatment ]
  13. Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD) [ Time Frame: 24 weeks after the end of treatment ]
  14. Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2) [ Time Frame: 24 weeks after the end of treatment ]
  15. Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3) [ Time Frame: 24 weeks after the end of treatment ]
  16. Percentage of Participants With On-treatment Viral Breakthrough [ Time Frame: 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 treatment

  17. Percentage of Participants With Viral Relapse [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Chronic hepatitis C viral infection
  • Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit)
  • HCV genotype 2 or 3
  • No previous treatment for hepatitis C infection

Exclusion criteria:

  • Evidence of cirrhosis at the time of screening
  • Evidence of hepatocellular carcinoma at the time of screening
  • Any other cause of relevant liver disease other than HCV
  • Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN)
  • Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215643


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Sponsors and Collaborators
Debiopharm International SA
Investigators
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Study Director: Novartis Pharmceuticals Novartis Pharmaceuticals

Publications of Results:
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Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT01215643     History of Changes
Other Study ID Numbers: CDEB025A2211
2010-020034-26 ( EudraCT Number )
First Posted: October 6, 2010    Key Record Dates
Results First Posted: August 30, 2016
Last Update Posted: August 30, 2016
Last Verified: July 2016

Keywords provided by Debiopharm International SA:
Chronic hepatitis C genotype 2
Chronic hepatitis C genotype 3
Cyclophilin inhibitor

Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Chronic Pain
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pain
Neurologic Manifestations
Signs and Symptoms
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs