Long-Term Follow-Up Safety Monitoring of Patients Dosed in the First-in-Man Phase I/II Study of TT-034.

Terminated

• Conditions: Hepatitis C

• Registration Number: NCT02315638
• Lead Sponsor: Tacere Therapeutics, Inc.

Brief Summary

This is a long-term safety follow-up protocol for subjects who received TT-034 under the B2801001 protocol and consists of monitoring for at least 4.5 years.

Detailed Description

The main purpose of this follow-up study is to detect events suggestive of delayed adverse effects of the study drug by review of clinical histories and discussion with subjects to identify/elicit significant medical events, including but not limited to hematologic, malignant, autoimmune, neurologic, and hepatic events.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-12
• Status Verified: 2018-09
• Primary Completion: 2018-09-24
• Study Completion: 2018-09-24
• Last Update Submitted: 2018-09-24
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Prior enrollment in Study B2801001 and dosing with TT-034
• An informed consent form for this study signed and dated by the subject or a legally acceptable representative

Exclusion Criteria

• There are no specific exclusion criteria for this follow-up study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long Term Safety as measured through an assessment of adverse events	4.5 years	The primary objective is to assess the long-term safety of TT-034 administered in subjects with CHC through an assessment of adverse events with a focus on hematologic, malignant, autoimmune, neurologic and hepatic events.

Secondary Outcome Measures

Name	Time	Method
Long Term Viral Load	4.5 years	The secondary objective is to monitor long-term HCV viral load, as available, of subjects who have received TT-034.

Trial Locations

Locations (1)

Duke Clinical Research Institute; 🇺🇸 Durham, North Carolina, United States