Long-Term Follow-Up Safety Monitoring of Patients Dosed i... | NCT02315638

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

NCT02315638

Sponsor

Tacere Therapeutics, Inc.

Status

Terminated

Last Update Posted

Sep 26, 2018Actual

Enrollment

9Actual

Phase

Not provided

Conditions

Hepatitis C

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Long term safety follow-up no longer required

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Sep 24, 2018Actual

Completion Date

Sep 24, 2018Actual

First Submitted Date

Dec 5, 2014

First Submission Date that Met QC Criteria

Dec 11, 2014

First Posted Date

Dec 12, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2018

Last Update Posted Date

Sep 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dosed subjects		There is no intervention. This is a observational study monitoring subjects that were dosed with TT-034 in the Tacere B2801001 study,

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Suhy, PhD	Tacere Therapeutics, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke Clinical Research Institute		Durham	North Carolina	27710	United States

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C
D006505	Hepatitis
D019698	Hepatitis C, Chronic

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided