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CTS-1027 in Interferon-Naive Hepatitis C
NCT00925990Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2009
- Primary completion
- May 2010
- Countries
- 2
- Sponsor
- Conatus Pharmaceuticals Inc.
- Modality
- Orthosteric Ligands
- Drugs
- CTS-1027
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 2, randomised, double-blind trial in hepatitis C (HCV) comparing CTS-1027 + Ribavirin with CTS-1027 + Placebo (2 arms). Primary endpoint: Mean Change in HCV-RNA Levels From Baseline at 24 weeks. Started Jun 2009; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
CTS-1027 + Ribavirin
CTS-1027 15mg BID + Ribavirin 1000/1200mg BID
CTS-1027 + Placebo
CTS-1027 15mg BID + Placebo BID
03
Who it enrols
Adult patients with chronic genotype 1 Hepatitis C who are unsuitable for interferon-based treatment due to psychiatric disorders, refusal, or investigator opinion. Patients must have compensated liver disease and no cirrhosis.
04
Endpoints
Primary
Mean Change in HCV-RNA Levels From Baseline
Secondary
Mean Change in Aminotransferases From Baseline
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