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

Tacere Therapeutics

Status: Terminated

Conditions: Hepatitis C

Study type: Observational

Funder types: Industry

Identifiers

NCT02315638

B2801002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Exclusion criteria

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

Trial design

9 participants in 1 patient group

Dosed subjects

Description:

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