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Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an Option

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02094443
Recruitment Status : Completed
First Posted : March 21, 2014
Results First Posted : October 13, 2016
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

Brief Summary:
The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed interferon therapy or were intolerant or unable to take interferon.

Condition or disease Intervention/treatment Phase
Hepatitis C Liver Disease Drug: Alisporivir Drug: Ribavirin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Randomized, 2-arm, Phase II Trial of Pharmacodynamics, Pharmacokinetics and Safety of Two Dose Regimens of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Patients Who Have Previously Failed Interferon Therapy or Are Intolerant or Unable to Take Interferon.
Study Start Date : March 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arm Intervention/treatment
Experimental: Alisporivir 300 mg BID
Alisporivir (ALV) 300 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication
Drug: Alisporivir
ALV 100 and 200 mg soft gel capsules administered orally
Other Name: DEB025

Drug: Ribavirin
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 Name: Copegus®

Experimental: Alisporivir 400 mg BID
ALV 400 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication
Drug: Alisporivir
ALV 100 and 200 mg soft gel capsules administered orally
Other Name: DEB025

Drug: Ribavirin
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 Name: Copegus®




Primary Outcome Measures :
  1. Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12 [ Time Frame: Baseline, Week 12 ]
    The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12.

  2. Change From Baseline in Alanine Aminotransferase (ALT) at Week 12 [ Time Frame: Baseline, Week 12 ]
    ALT levels were assessed as part of clinical chemistry assessments throughout the study as a measure of biochemical liver recovery. A negative change from baseline indicates less liver damage.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment [ Time Frame: Up to 24 weeks posttreatment ]
    SVR is defined as HCV RNA less than the lower limit of quantification (LLOQ), i.e., <15 IU/mL, at 4 weeks (SVR4), 12 weeks (SVR12), and 24 weeks (SVR24) after treatment, respectively.

  2. Percentage of Participants With Extended Rapid Virologic Response [ Time Frame: 2 weeks ]
    Extended rapid virologic response (eRVR) was defined as serum HCV RNA < LLOQ after 2 weeks of treatment

  3. Percentage of Participants With Rapid Virologic Response (RVR) [ Time Frame: 4 weeks ]
    eRVR was defined as serum HCV RNA < LLOQ after 4 weeks of treatment

  4. Percentage of Participants With End of Treatment Response (ETR) [ Time Frame: Up to 24 weeks ]
    ETR was defined as serum HCV RNA < LLOQ at treatment end (completed or prematurely discontinued).

  5. Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End [ Time Frame: Up to 24 weeks ]
    ALT is an enzyme found mostly in the cells of the liver and kidney. When the liver is damaged, ALT is released into the blood. This makes ALT a common test for liver damage, because higher ALT levels may indicate more liver damage. ALT upper limit of normal is commonly considered to be 40 international units per liter (IU/L), so abnormal ALT is above 40 IU/L.



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

Inclusion Criteria:

  1. Written informed consent must be obtained before any assessment is performed
  2. Participants with HCV genotype 2 or 3 infection who have previously failed interferon therapy or are intolerant or unable to take interferon
  3. Males or females aged ≥18 years
  4. Diagnosed Chronic hepatitis C virus infection

Exclusion criteria:

  1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment
  2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
  3. Hepatitis B surface antigen (HBsAg) positive
  4. Human immunodeficiency virus (HIV) positive

Other protocol-defined inclusion/exclusion criteria 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): NCT02094443


Locations
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United States, California
Novartis Investigative Site
Bakersfield, California, United States, 93301
Novartis Investigative Site
Lancaster, California, United States, 93534
Novartis Investigative Site
San Diego, California, United States, 92114
Novartis Investigative Site
San Diego, California, United States, 92128
United States, Missouri
Novartis Investigative Site
St. Louis, Missouri, United States, 63110
United States, Texas
Novartis Investigative Site
Arlington, Texas, United States, 76012
Novartis Investigative Site
Houston, Texas, United States, 77030
Novartis Investigative Site
San Antonio, Texas, United States, 78215
United States, Virginia
Novartis Investigative Site
Newport News, Virginia, United States, 23602
United States, Washington
Novartis Investigative Site
Seattle, Washington, United States, 98101
Novartis Investigative Site
Seattle, Washington, United States, 98104
France
Novartis Investigative Site
Clichy, France, 92110
Novartis Investigative Site
Creteil, France, 94010
Novartis Investigative Site
Lyon Cedex 04, France, 69317
Novartis Investigative Site
Nice Cedex 3, France, 06202
Novartis Investigative Site
Paris, France, 75014
Sponsors and Collaborators
Debiopharm International SA
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT02094443    
Other Study ID Numbers: CDEB025A2233
2013-003751-38 ( EudraCT Number )
First Posted: March 21, 2014    Key Record Dates
Results First Posted: October 13, 2016
Last Update Posted: October 13, 2016
Last Verified: August 2016
Keywords provided by Debiopharm International SA:
Chronic hepatitis C genotype 2
Chronic hepatitis C genotype 3
Cyclophilin inhibitor
Interferon intolerant
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents