Trial · NCT04202965

PTG-300 in Subjects With Hereditary Hemochromatosis

NCT04202965, Phase 2, Completed, Protagonist Therapeutics, Inc.; results first posted 2023-06-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. PTG-300 in Subjects With Hereditary Hemochromatosis. Trials, record NCT04202965. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04202965

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: PTG-300 in Subjects With Hereditary Hemochromatosis
NCT number: NCT04202965
Status: Completed
Phases: Phase 2
Enrollment: 16 participants, actual
Lead sponsor: Protagonist Therapeutics, Inc.
Conditions: Hereditary Hemochromatosis
Interventions: PTG-300
First posted: 2019-12-18
Last updated: 2025-08-20
Results first posted: 2023-06-15

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Effect of PTG-300 on Transferrin Saturation	Week 24 (or End of Treatment if treated for less than 24 weeks)	Change from Baseline to Week 24 (or End of Treatment) in transferrin saturation (TSAT) as measured by blood laboratory tests.
Primary	Effect of PTG-300 on Serum Iron	Week 24 (or End of Treatment if treated for less than 24 weeks)	Change from Baseline to Week 24 (or End of Treatment) in serum iron as measured by blood laboratory tests.
Secondary	Effect of PTG-300 on Phlebotomy Frequency	Over 24 weeks	Change in number of phlebotomies in 24-weeks before treatment compared with the number of phlebotomies during 24-weeks of treatment with PTG-300.
Other	Mental Component Summary of SF-36	Week 24 (or End of Treatment if treated for less than 24 weeks)	Change from Baseline to Week 24 (or End of Treatment) in Mental Component Summary of the SF-36. The SF-36 is a questionnaire of health status based on 36 questions distributed into eight domains of daily life that are frequently evaluated as influenced by disease. Values in each domain range from 0 to 100, with higher scores indicating better health condition. A summary measure, Mental Component Summary (MCS), for mental health can be calculated. The MCS ranges from 0 (low functioning) to 100 (high functioning).
Other	Physical Component Summary of SF-36	Week 24 (or End of Treatment if treated for less than 24 weeks)	Change from Baseline to Week 24 (or End of Treatment) in Physical Component Summary of the SF-36. The SF-36 is a questionnaire of health status based on 36 questions distributed into eight domains of daily life that are frequently evaluated as influenced by disease. Values in each domain range from 0 to 100, with higher scores indicating better health condition. A summary measure, Physical Component Summary (PCS), for mental health can be calculated. The PCS ranges from 0 (low functioning) to 100 (high functioning).

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Effect of PTG-300 on Transferrin Saturation	Week 24 (or End of Treatment if treated for less than 24 weeks)	Subjects who had paired values to allow determination of change from baseline	percent saturation	MEAN
PRIMARY	Effect of PTG-300 on Serum Iron	Week 24 (or End of Treatment if treated for less than 24 weeks)	Subjects who had paired values to allow determination of change from baseline	micromol/L	MEAN
SECONDARY	Effect of PTG-300 on Phlebotomy Frequency	Over 24 weeks	Enrolled population	phlebotomies/week	MEAN
OTHER_PRE_SPECIFIED	Mental Component Summary of SF-36	Week 24 (or End of Treatment if treated for less than 24 weeks)	Subjects who have a Score at Baseline and at Week 24 or End of Treatment	units on a scale	MEAN
OTHER_PRE_SPECIFIED	Physical Component Summary of SF-36	Week 24 (or End of Treatment if treated for less than 24 weeks)	Subjects who have a Score at Baseline and at Week 24 or End of Treatment	units on a scake	MEAN

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Effect of PTG-300 on Transferrin Saturation	PTG-300	-6.07	Standard Deviation 19.4	percent saturation
Effect of PTG-300 on Serum Iron	PTG-300	-2.34	Standard Deviation 9.76	micromol/L
Effect of PTG-300 on Phlebotomy Frequency	PTG-300	0.00	Standard Deviation 0.01	phlebotomies/week
Mental Component Summary of SF-36	PTG-300	-0.251	Standard Deviation 9.379	units on a scale
Physical Component Summary of SF-36	PTG-300	2.263	Standard Deviation 6.528	units on a scake

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PTG-300	16
Overall Study	COMPLETED	PTG-300	12
Overall Study	NOT COMPLETED	PTG-300	4

Source ClinicalTrials.gov

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhea	Gastrointestinal disorders	PTG-300	2	16
other	Dry mouth	Gastrointestinal disorders	PTG-300	1	16
other	Nausea	Gastrointestinal disorders	PTG-300	1	16
other	Vomiting	Gastrointestinal disorders	PTG-300	1	16
other	Supraventricular extrasystoles	Cardiac disorders	PTG-300	1	16
other	Fatigue	General disorders	PTG-300	2	16
other	Inflammation	General disorders	PTG-300	1	16
other	Injection site bruising	General disorders	PTG-300	1	16
other	Injection site discomfort	General disorders	PTG-300	1	16
other	Injection site erythema	General disorders	PTG-300	2	16

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PTG-300	0	16
Total, other adverse events	PTG-300	12	16
Total, serious adverse events	PTG-300	1	16

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37863080	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04202965

GET https://conductscience.org/api/trials/v1/NCT04202965/events?page=2

API reference For AI assistants