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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Achillion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01700179
First received: October 2, 2012
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Chronic Hepatitis C Infection
Drug: ACH-0143102
Drug: Ribavirin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Achillion Pharmaceuticals:

Primary Outcome Measures:
  • SVR12 [ Time Frame: 12 weeks following last dose ] [ Designated as safety issue: No ]
    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


Enrollment: 8
Study Start Date: September 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700179

Locations
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
Achillion Pharmaceuticals
  More Information

No publications provided

Responsible Party: Achillion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01700179     History of Changes
Other Study ID Numbers: ACH102-005
Study First Received: October 2, 2012
Results First Received: September 30, 2014
Last Updated: October 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Infection
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014