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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02315638
• Other study ID #: B2801002
• Status: Terminated
• Start date: November 2014
• Est. completion date: September 24, 2018

Study information

• Verified date: September 2018
• Source: Tacere Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 24, 2018
• Est. primary completion date: September 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Locations

Country	Name	City	State
United States	Duke Clinical Research Institute	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Tacere Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4.5 years
Secondary	Long Term Viral Load	The secondary objective is to monitor long-term HCV viral load, as available, of subjects who have received TT-034.	4.5 years