Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants

Study Identifier:
ACH102-005
ClinicalTrials.gov Identifier:
NCT01700179
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: ACH-0143102
  • Drug: Ribavirin
Date
Sep 2012 - Sep 2013
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Males and females aged 18 years and older.
  • Clinical diagnosis of hepatitis C with GT1b.
  • Chronic hepatitis C treatment-naive participants.
  • Interleukin 28B genotype CC.
  • HCV ribonucleic acid \> 10,000 international units/milliliter at screening.
  • Female participants must be willing to use 2 effective methods of contraception during the dosing period and for 6 months after the last dose of ribavirin.
  • Male participants must be willing to use an effective barrier method of contraception throughout the dosing period and for 6 months after the last dose of ribavirin. Male participants must agree not to donate sperm while enrolled in the study and for 6 months after the last dose of ribavirin.
  • Willing to participate in all study activities and all study requirements.
Exclusion Criteria
  • Body mass index \> 36 kilograms/meter squared.
  • Pregnant or nursing females.
  • Clinically significant laboratory abnormalities at screening.
  • Previous participation in a clinical trial with protease inhibitor and/or non-structural protein 5A inhibitor.
  • Human immunodeficiency virus 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.
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: ACH-0143102
  • Drug: Ribavirin
Date
Sep 2012 - Sep 2013
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Males and females aged 18 years and older.
  • Clinical diagnosis of hepatitis C with GT1b.
  • Chronic hepatitis C treatment-naive participants.
  • Interleukin 28B genotype CC.
  • HCV ribonucleic acid \> 10,000 international units/milliliter at screening.
  • Female participants must be willing to use 2 effective methods of contraception during the dosing period and for 6 months after the last dose of ribavirin.
  • Male participants must be willing to use an effective barrier method of contraception throughout the dosing period and for 6 months after the last dose of ribavirin. Male participants must agree not to donate sperm while enrolled in the study and for 6 months after the last dose of ribavirin.
  • Willing to participate in all study activities and all study requirements.
Exclusion Criteria
  • Body mass index \> 36 kilograms/meter squared.
  • Pregnant or nursing females.
  • Clinically significant laboratory abnormalities at screening.
  • Previous participation in a clinical trial with protease inhibitor and/or non-structural protein 5A inhibitor.
  • Human immunodeficiency virus 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.

Protocol Summary

The purpose of this study was to evaluate the safety, tolerability, and efficacy of 12 weeks of treatment with ACH-0143102 and ribavirin in genotype 1b (GT1b), treatment-naive, hepatitis C virus (HCV) participants.

Trial Locations

No locations found.