Safety, Tolerability, and Efficacy of 12-weeks of Sovaprevir, ACH-3102, and Ribavirin in Treatment-naive GT-1 HCV Participants

Hepatitis C, Chronic Clinical Trial

Official title:

A Phase 2a Trial to Evaluate the Safety, Tolerability, and Efficacy of 12 Weeks of Sovaprevir, ACH-0143102 and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotype-1 Viral Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01849562
• Other study ID #: ACH102-007
• Status: Completed
• Phase: Phase 2
• Start date: April 2013
• Est. completion date: April 2014

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 sovaprevir, ACH-0143102, and ribavirin (RBV) in genotype-1 (GT-1), treatment-naive, hepatitis C virus (HCV) participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Chronic HCV infection.

• HCV GT-1.

• HCV ribonucleic acid > 10,000 international units/milliliter at screening.

• Female participants must be willing to use 2 effective methods of contraception, one of which must be a barrier method, during the dosing period and 6 months after the last dose of RBV. Females of childbearing potential must have a negative pregnancy test at screening and baseline.

• Male participants must be willing to use an effective barrier method of contraception throughout the dosing period and for 6 months.

• Signed and dated written informed consent form.

• Willing to participate in all study activities and all study requirements (including effective contraception) during the study period.

• Treatment-naïve participants were defined as those participants who have never received pegylated interferon, RBV, or a direct-acting anti-viral agent for the treatment of chronic HCV infection.

• A liver biopsy within the last 3 years without evidence of cirrhosis.

Exclusion Criteria:

• Body mass index > 36.0 kilograms/meter squared.

• Pregnant or nursing (lactating) female participants confirmed by a positive human chorionic gonadotropin laboratory test or contemplating pregnancy.

• Participation in any interventional clinical trial within 35 days prior to first study medication dose administration on Day 1.

• Known human immunodeficiency virus (HIV)-1 or HIV-2 infection/serology and/or positive hepatitis B surface antigen.

• Use of dietary supplements, grapefruit juice, herbal supplements, cytochrome P450 (CYP) 2C8 substrates, CYP3A4 inducers and inhibitors, P-glycoprotein inducers and substrates, organic-anion-transporting polypeptide inhibitors and substrates, and potent inducers of other CYP enzymes within 14 days prior to dosing through 7 days following completion of study medications.

• Clinically significant laboratory abnormality at screening (specified in protocol).

• Other forms of liver disease.

• History of severe or uncontrolled psychiatric disease.

• History of malignancy of any organ system, treated or untreated within the past 5 years.

• History of major organ transplantation.

• Use of bone marrow colony stimulating factor agents within 3 months prior to baseline.

• History of seizure disorder requiring ongoing medical therapy.

• History of known coagulopathy including hemophilia.

• History of hemoglobinopathy, including sickle cell anemia and thalassemia.

• History of immunologically mediated disease (specified in protocol).

• History of clinical evidence of significant chronic cardiac disease ( specified in protocol).

• Electrocardiogram with any clinically significant abnormality.

• Structural or functional cardiac abnormalities (specified in protocol).

• History of chronic obstructive pulmonary disease, emphysema, or other chronic lung disease.

• Participants currently abusing amphetamines, cocaine or opiates, or with ongoing alcohol abuse in the judgement of the investigator.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• Sovaprevir
Nonstructural protein 3/4A protease inhibitor.
• ACH-3102
Nonstructural protein 5A inhibitor.
• Ribavirin

• Placebo

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	Incidence Of Sustained Virologic Response 4 Weeks (SVR4) After The Completion Of Treatment	Incidence of SVR4 after the completion of dosing, reported as hepatitis C virus (HCV) ribonucleic acid less than the lower limit of quantification, in participants who received active treatment (sovaprevir and ACH-0143102 in combination with RBV) as compared to those who received placebo.	Four weeks after the completion of treatment
Primary	Safety And Tolerability Of 12 Weeks Of Sovaprevir And ACH-3102 In Combination With RBV In GT-1 HCV Participants	To determine the safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV treatment in participants with chronic genotype-1 (GT-1) HCV, the following criteria will be used: the number of participants with discontinuations due to adverse events (AEs), treatment-emergent Grade 3/Grade 4 (G3/G4) AEs, treatment-emergent G3/G4 laboratory abnormalities, and clinically significant electrocardiograms (ECGs).	12 weeks