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Evaluation of Safety Tolerability and Antiviral Activity of ACH-0143102 Plus RBV Treatment Naive HCV GT1b Subjects

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: NCT01700179
Recruitment Status : Completed
First Posted : October 4, 2012
Results First Posted : October 3, 2014
Last Update Posted : October 10, 2014
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety, tolerability and efficacy of 12 weeks of treatment with ACH-0143102 and ribavirin in GT1b, treatment-naive, HCV subjects.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Infection Drug: ACH-0143102 Drug: Ribavirin Phase 1

Detailed Description:
A phase 1b, pilot study to evaluate the safety, tolerability and antiviral activity of oral ACH-0143102 administered in combination with ribavirin for 12 weeks in treatment naive subjects with chronic hepatitis C virus infection genotype 1b.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b, Open-label, Pilot Study to Evaluate the Safety, Tolerability and Antiviral Activity of Oral ACH-0143102 Administered in Combination With Ribavirin for 12 Weeks in Treatment Naive Subjects With Chronic Hepatitis C Virus Infection Genotype 1b.
Study Start Date : September 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arms and Interventions
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Arm Intervention/treatment
Experimental: ACH-0143102 plus ribavirin daily
ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV(as per label) for Days 1-84.
 Drug: ACH-0143102
Drug: Ribavirin


Outcome Measures
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Primary Outcome Measures :
  1. SVR12 [ Time Frame: 12 weeks following last dose ]
    To determine the incidence of a sustained virologic response at 12 weeks after the completion of dosing (SVR12) with ACH-0143102 plus ribavirin, reported as HCV RNA less than the limit of quantification (<LOQ) at that time point


Eligibility Criteria
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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:

  • Males and females 18 years and older
  • Clinical diagnosis of hepatitis C with genotype 1b
  • Chronic hepatitis C treatment naive subjects
  • IL28B genotype CC
  • HCV RNA > 10000 IU/mL at screening
  • Females must be willing to use two effective methods of contraception during dosing period and for six months after the last dose of ribavirin.
  • Male patients must be willing to use an effective barrier method of contraception throughout the dosing period and for six months after the last dose of ribavirin. Males must agree to not donate sperm while enrolled in the study and for six months after the last dose of ribavirin.
  • Willing to participate in all study activities and all study requirements.

Exclusion Criteria:

  • BMI>36
  • Pregnant or nursing females
  • Clinically significant laboratory abnormalities at screening
  • Previous participation in a clinical trial with protease inhibitor and/or NS5A inhibitor
  • HIV infection or other liver diseases
  • Positive Hepatitis B Surface Antigen
  • Liver cirrhosis
  • Uncontrolled psychiatric disease
  • Clinical evidence of chronic cardiac disease
  • History of malignancy of any organ system within 5 years
Contacts and Locations
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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): NCT01700179


Locations
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United States, Georgia
Dr. Aasim Sheikh
Marietta, Georgia, United States, 30060
United States, Tennessee
Dr. Robert Herring Jr
Nashville, Tennessee, United States, 37211
United States, Texas
Victor Ankoma-Sey
Houston, Texas, United States, 77030
United States, Virginia
Vinod Rustgi, MD
Fairfax, Virginia, United States, 22031
Robert Brennan
Lynchburg, Virginia, United States, 24501
Michael Ryan, MD
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Alexion Pharmaceuticals
More Information
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Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01700179    
Other Study ID Numbers: ACH102-005
First Posted: October 4, 2012    Key Record Dates
Results First Posted: October 3, 2014
Last Update Posted: October 10, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Infection
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents