Long-Term Follow-Up Safety Monitoring of Patients Dosed in the First-in-Man Phase I/II Study of TT-034.
| Status: | Terminated |
|---|---|
| Conditions: | Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/28/2018 |
| Start Date: | November 2014 |
| End Date: | September 24, 2018 |
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
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.
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.
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.
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
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