CompletedPhase 2ACTRN12614000307606

An open label study to investigate the safety and efficacy of treatment with ACH-0143102 and sofosbuvir in hepatitis C patients

A phase 2, open-label, randomized, controlled, partial crossover study to evaluate the efficacy, safety and tolerability of 8 weeks or 6 weeks of ACH-0143102 and sofosbuvir in treatment-naive subjects with chronic hepatitis C genotype-1 viral infection

Sponsor

Achillion Pharmaceuticals, Inc

Enrollment

36 participants

Start Date

Mar 31, 2014

Study Type

Interventional

Conditions

Hepatitis C

Summary

This study will evaluate whether 6 or 8 weeks treatment with two antiviral agents, Sofosbuvir and ACH0143102, will be safe and effective in patients infected with Hepatitis C genotype 1 who have never been treated. The study is divided into 2 groups and will enrol up to 36 people. The study will initially randomize 18 subjects in an open label fashion into two treatment groups: Group 1A and Group 1B. Twelve (12) subjects will receive active treatment (50 mg ACH0143102 + 400 mg sofosbuvir) starting on Day 1 for 8 weeks (Group 1A), and be followed for an additional 24 weeks. The other 6 subjects (Group 1B) will have a 12 week observational period, in which they will receive no treatment. Group 2 will only proceed if 100% of the subjects in Group 1A have virus not detected in the blood at 4 weeks after treatment is finished. A total of approximately 18 subjects could participate in Groups 2A and 2B. Up to six subjects from Group 1B will enter Group 2A. In addition, 12 new subjects will be randomized (1:1) in an open label fashion to either Group 2A (active treatment with 50 mg of ACH0143102 + 400 mg of sofosbuvir for 6 weeks) or to Group 2B (observational period). Subjects in Groups 1B or 2B who received no treatment will be offered either 6 or 8 weeks of the same regime, depending on the results of the Groups 1A and 2A. Every patient will be checked throughout the study to ensure that the treatment is working and to record any side effects

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria6

Chronic HCV infection
HCV GT-1
HCV RNA greater than 10,000 IU/mL at screening
Signed and dated written consent
Treatment naive subjects
Biopsy or fibroscan confirming no evidence of cirrhosis

Exclusion Criteria7

BMI greater than 36kg/m2
Pregnant or lactating females. Men whose female partners are pregnant or contemplating pregnancy
Clinically significant laboratory abnormality at screening
Known HIV infection
Positive hepatits B surface antigen
History of participation in a clinical trial with pegylated interferon, RBV, or a direct-acting anti-viral agent, or previous treatment with any of these where at least one dose was taken
Use of dietary supplements, herbal supplements, potent PGP inducers in the intestine, anticonvulsants, antimycobacterials and HIV protease inhibitors.

Print for Your Doctor

Interventions

Active treatment is ACH-0143102 (2 x 25mg capsules) and sofosbuvir (1 x 400mg tablet) to be taken orally once a day. The study is divided into 2 groups and will enrol up to 36 people. The study wil

Active treatment is ACH-0143102 (2 x 25mg capsules) and sofosbuvir (1 x 400mg tablet) to be taken orally once a day. The study is divided into 2 groups and will enrol up to 36 people. The study will initially randomize 18 subjects in an open label fashion into two treatment groups: Group 1A and Group 1B. Twelve (12) subjects will receive active treatment (50 mg ACH-0143102 + 400 mg sofosbuvir) starting on Day 1 for 8 weeks (Group 1A), and be followed for an additional 24 weeks. The other 6 subjects (Group 1B) will have a 12 week observational period, in which they will receive no treatment. Group 2 will only proceed if 100% of the subjects in Group 1A have virus not detected in the blood at 4 weeks after treatment is finished. A total of approximately 18 subjects could participate in Groups 2A and 2B. Up to six subjects from Group 1B will enter Group 2A. In addition, 12 new subjects will be randomized (1:1) in an open label fashion to either Group 2A (active treatment with 50 mg of ACH-0143102 + 400 mg of sofosbuvir for 6 weeks) or to Group 2B (observational period). Subjects in Groups 1B or 2B who received no treatment will be offered either 6 or 8 weeks of the same regime, depending on the results of the Groups 1A and 2A. Every patient will be checked throughout the study to ensure that the treatment is working and to record any side effects Medication compliance will be monitored by tablet/capsule count at each study visit. Subjects randomized to the 8 week regime will be required to attend clinic visits on 17 occasions over a 32 week period - a screening visit, a day 1 (baseline visit), a visit once a week for 8 weeks, and then for 8 follow up visits (at week 10, 12, 16, 20, 24, 28 and 32). Those subjects who are randomised to the observation period will not be required to attend clinic after week 12. Subjects randomized to the 6 week regime will be required to attend clinic visits on 15 occasions over a 30 week period - a screening visit, a day 1 (baseline visit), a visit once a week for 6 weeks, and then for 7 follow up visits (at week 8, 10, 14, 18, 22, 26 and 30. Those subjects who are randomised to the observation period will not be required to attend clinic after week 10. Follow up visits will include a range of assessments (vital signs, pregnancy tests, safety laboratory tests, ECGs, adverse event assessments, concomitant medication review) and PK sampling. No washout period is required as the only participants who are permitted to cross over are participants who did not receive any treatment.