Trial · Interventional
CompletedPhase 2Registry dataStudy of PTG-300 in Non-Transfusion Dependent and Transfusion-Dependent Beta-Thalassemia Subjects With Chronic Anemia
Short name TRANSCEND
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 63 participants (actual)
- Sponsor
- Protagonist Therapeutics, Inc. · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
9 countries
United States, Greece, Italy, Lebanon, Malaysia, Thailand, Tunisia, Turkey (Türkiye), United Kingdom
- Start
- 19 Dec 2018
- Primary completion
- 31 Jul 2020
- Completion
- 31 Jul 2020
- First posted
- 14 Jan 2019
- Last update posted
- 16 Jul 2021
- Conditions
- β-thalassemia · Ineffective Erythropoiesis · Chronic Anemia
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a Phase 2 open-label, single-arm design study with dose escalation by subject cohort . The study is designed to monitor the PTG-300 safety profile, to obtain preliminary evidence of efficacy of PTG-300 for the treatment in β-thalassemia.
Interventions
- PTG-300Drug
Arms1
Experimental
PTG-300 Active
Drug: PTG-300 Subcutaneous
Primary outcomes2
Outcomes the sponsor listed as primary.
NTD: Proportion of responders at each dose
Time frame · 4 week period
Registry description
NTD subjects who achieve an increase in Hgb without transfusion
TD: Proportion of clinical responders at each dose
Time frame · 8 week period
Registry description
TD subjects who achieve a reduction in red blood cell (RBC) units required over an 8 week period
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 12 Years up to 65 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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