Phase 1 N=8 Treatment

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

Chronic Hepatitis C Infection

Bottom Line

View on ClinicalTrials.gov: NCT01700179 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcome: Primary: Sustained Virologic Response At 12 Weeks (SVR12) — 50 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: ACH-0143102 (Drug); Ribavirin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alexion Pharmaceuticals, Inc.
Primary completion: Sep 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Sustained Virologic Response At 12 Weeks (SVR12)	50	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01700179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.