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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02315638

Enrollment

Registered

2014-12-12

Start date

2014-11-30

Completion date

2018-09-24

Last updated

2018-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Adeno-associated viral vectors, Adeno-associated virus, AAV, AAV8, ddRNAi, shRNA, RNAi, Hepatitis, Chronic Hepatitis C, HCV, CHC, Genotype 1

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results