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

Sponsor

Tacere Therapeutics, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02315638

Collaborator

(none)

Enrollment

Location

46.8

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C

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 Design

Study Type:

Observational

Actual Enrollment :

9 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Follow-up to Study Protocol B2801001, A Phase I/II, Open-Label Dose Escalation Study to Evaluate the Safety and Efficacy of Single Doses of TT-034 in Patients With Chronic Hepatitis C [CHC] Infection

Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Sep 24, 2018

Actual Study Completion Date :

Sep 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Dosed subjects There is no intervention. This is a observational study monitoring subjects that were dosed with TT-034 in the Tacere B2801001 study,

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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