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NCT01273064 · ClinicalTrials.gov registry record · Phase 2
Standard of Care (SOC) With or Without CTS-1027 in Hepatitis C (HCV) Null-Responders
A Phase 2 study, sponsored by Conatus Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
NCT01273064 is a Phase 2 study that was terminated before completion, run by Conatus Pharmaceuticals. The registered enrollment target is 114 participants.
The verdict
NCT01273064, a Phase 2 study, was terminated before completion, sponsored by Conatus Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
Study Summary
Placebo controlled, double-blind, multicenter study utilizing standard of care (SOC) treatment (ribavirin plus pegylated interferon) in combination with CTS-1027 in genotype 1 chronic Hepatitis C (HCV) patients who were null-responders to previous SOC therapy(ies). Null-responders are defined as patients who failed to achieve a greater than 2 log drop in HCV-RNA (Hepatitis C Ribonucleic acid, also known as "viral load") levels after 12 weeks of treatment (know as an "early virologic response", or EVR) during previous SOC therapy. If, during previous SOC treatment, a patient had a less than 2 log decline in HCV-RNA at Week 12 but greater than 2 log decline in HCV-RNA at any time from Week 12 to Week 24, that patient is not a null-responder, and is excluded from study participation. If, during previous SOC treatment, a Week 12 HCV-RNA was not obtained, the post Week 12 response must have been \< 2 log decline (and still HCV-RNA positive) in order for the patient to be defined as a null-responder. Patients will be screened and have up to 4 weeks to qualify for study entry. During this screening period, clinical and laboratory tests will be performed. At Week 0/Day 1, patients will undergo centralized, stratified (based on ethnicity), randomization to one of four treatment arms: SOC + one of three doses of CTS-1027 or SOC + placebo. Study treatment will last 24, 48, or 60 weeks, based on each patient's response to study treatment. SOC + placebo patients who do not show a virologic response after 12 weeks of therapy will be rolled onto SOC + 15mg CTS-1027, while maintaining the study blind.
Interventions
- DRUG Placebo
- DRUG Ribavirin
- DRUG CTS-1027
- DRUG pegylated interferon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2011-01 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01273064
The ClinicalTrials.gov registry entry for NCT01273064 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Conatus Pharmaceuticals, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01273064 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01273064 about?
NCT01273064 is a clinical study titled "Standard of Care (SOC) With or Without CTS-1027 in Hepatitis C (HCV) Null-Responders". Placebo controlled, double-blind, multicenter study utilizing standard of care (SOC) treatment (ribavirin plus pegylated interferon) in combination with CTS-1027 in genotype 1 chronic Hepatitis C (HCV) patients who were null-responders to previous SOC therapy(ies). Null-responders are defined as pa...
What is the current status of trial NCT01273064?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2011-01. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01273064?
The interventions under investigation include: Placebo (DRUG), Ribavirin (DRUG), CTS-1027 (DRUG), pegylated interferon (DRUG).
Who is sponsoring clinical trial NCT01273064?
This trial is sponsored by Conatus Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.
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