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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700179
• Other study ID #: ACH102-005
• Status: Completed
• Phase: Phase 1
• Start date: September 2012
• Est. completion date: September 2013

Study information

• Verified date: August 2023
• Source: Alexion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A Phase 1b, pilot study that evaluated the safety, tolerability, and antiviral activity of oral ACH-0143102 administered in combination with ribavirin for 12 weeks in treatment-naive participants with chronic HCV GT1b.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infections
• Virus Diseases

Intervention

Drug:
• ACH-0143102

• Ribavirin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alexion	Achillion, a wholly owned subsidiary of Alexion

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virologic Response At 12 Weeks (SVR12)	To determine the incidence of the SVR12 after the completion of dosing with ACH-0143102 plus ribavirin, reported as hepatitis C virus ribonucleic acid less than the limit of quantification at that time point.	12 weeks following the last dose