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

Tacere Therapeutics, Inc.9 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hepatitis C

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke Clinical Research Institute

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Long Term Safety as measured through an assessment of adverse events

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.

Time frame: 4.5 years

Secondary Outcomes

Long Term Viral Load

The secondary objective is to monitor long-term HCV viral load, as available, of subjects who have received TT-034.

Time frame: 4.5 years

Data from ClinicalTrials.gov

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