Safety Study for Beta Thalassemia Subjects on PTG-300 | NCT04054921

Studies
Safety Study for Beta Thalassemia Subjects on PTG-300

NCT04054921

Sponsor

Protagonist Therapeutics, Inc.

Status

Completed

Last Update Posted

Jul 16, 2021Actual

Enrollment

34Actual

Phase

Phase 2

Conditions

β-thalassemia
Ineffective Erythropoiesis

Interventions

PTG-300

Countries

United States
Greece
Lebanon
Malaysia
Thailand
Tunisia
Turkey (Türkiye)
United Kingdom

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

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2019Actual

Primary Completion Date

Jul 31, 2020Actual

Completion Date

Jul 31, 2020Actual

First Submitted Date

Aug 8, 2019

First Submission Date that Met QC Criteria

Aug 12, 2019

First Posted Date

Aug 13, 2019Actual

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

Jul 9, 2021

Certification/Extension First Submitted that Passed QC Review

Jul 12, 2021

Certification/Extension First Posted Date

Jul 16, 2021Actual

Last Update Submitted Date

Jul 12, 2021

Last Update Posted Date

Jul 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

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

In this study will investigate long term safety and use of the PTG-300 in Beta Thalassemia patients.

Detailed Description

The PTG-300-03 study will study beta thalassemia patients on PTG-300 for two years. The dose and dose frequency for each subject enrolling in the PTG-300-03 study will be based on the last dose and frequency received by the subject in the previous study PTG-300-02 and the subject's response at that dose. Patients dose will be increased in a manner similar to that used on PTG-300-02 study. The maximum PTG-300 dose allowed is 80 mg/week.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interventions	Experimental	PTG-300	Drug: PTG-300

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PTG-300	Drug	PTG-300 is a hepcidin Mimetic	Interventions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of subjects with side effects and severity of side effects will be tabulated	the long-term safety and tolerability of PTG-300 in Beta Thalassemia.	Over two year Period after receiving PTG-300

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

NTD and TD β-thalassemia subjects who completed Week 12 and Week 16 respectively in Study PTG-300-02.

Exclusion Criteria:

Subjects who discontinued prematurely from study 300-02 (before Week 12 in NTD and Week 16 in TD).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSF Benioff Children's Hospital		Oakland	California	94609	United States
Boston Children's Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided