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

NCT02315638 | Terminated

• 1 other identifier: B2801002
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 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.

Conditions

Hepatitis C

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Long Term Viral Load

  4.5 years

Study Arms (1)

Dosed subjects

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is comprised of subjects that were enrolled in Study B2801001 and who received a dose of TT-034.

You may qualify if:

• 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

Sponsors & Collaborators

• Tacere Therapeutics, Inc.: lead

Study Sites (1)

Duke Clinical Research Institute

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected and archived for further testing, should future data suggest that it is clinically or scientifically indicated.

MeSH Terms

Conditions

Hepatitis C; Hepatitis; Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Suhy, PhD

  Tacere Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 12, 2014
• Study Start: November 1, 2014
• Primary Completion: September 24, 2018
• Study Completion: September 24, 2018
• Last Updated: September 26, 2018

Record last verified: 2018-09

Locations

US (1)