Long-Term Follow-Up Safety Monitoring of Patients Dosed in the First-in-Man Phase I/II Study of TT-034.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02315638|
Recruitment Status : Terminated (Long term safety follow-up no longer required)
First Posted : December 12, 2014
Last Update Posted : September 26, 2018
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||9 participants|
|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|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||September 24, 2018|
|Actual Study Completion Date :||September 24, 2018|
There is no intervention. This is a observational study monitoring subjects that were dosed with TT-034 in the Tacere B2801001 study,
- Long Term Safety as measured through an assessment of adverse events [ Time Frame: 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.
- Long Term Viral Load [ Time Frame: 4.5 years ]The secondary objective is to monitor long-term HCV viral load, as available, of subjects who have received TT-034.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315638
|United States, North Carolina|
|Duke Clinical Research Institute|
|Durham, North Carolina, United States, 27710|
|Study Director:||David Suhy, PhD||Tacere Therapeutics, Inc.|