NCT05138887 is a Phase 2 clinical trial of Tetrahydrobiopterin in Radiation Enteritis, sponsored by West China Second University Hospital.

Who is sponsoring NCT05138887?

NCT05138887 is sponsored by West China Second University Hospital.

What drugs are being tested in NCT05138887?

Interventions in NCT05138887: Tetrahydrobiopterin.

What condition does NCT05138887 study?

NCT05138887 studies Radiation Enteritis.

Is NCT05138887 still recruiting?

NCT05138887 is currently status unknown. Last updated 2 March 2022.

Last reviewed 2022-03-02 · How we verify

NCT05138887

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study for Assessing the Efficacy and Safety of BH4 in Radiation Enteritis

Status unknown Phase 2 Last updated 2 March 2022

What this trial tests

Phase 2 trial testing Tetrahydrobiopterin in Radiation Enteritis in 366 participants. Status unknown.

Timeline

1 March 2022

Primary endpoint
1 October 2023

1 March 2024

Quick facts

Lead sponsor	West China Second University Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	366
Start date	1 March 2022
Primary completion	1 October 2023
Estimated completion	1 March 2024
Sites	1 location across China

Drugs / interventions tested

Tetrahydrobiopterin — full drug profile →

Conditions studied

Radiation Enteritis — all drugs for Radiation Enteritis →

Sponsor

West China Second University Hospital

Who can join

18 and older, female only, with Radiation Enteritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This present study envisaged a single-center, prospective, open-label, placebo and randomized controlled phase II clinical study to assess the efficacy and Safety of Tetrahydrobiopterin in Treating Radiation Enteritis in Gynecological Cancer Patients.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Biopterin metabolism and nitric oxide recoupling in cancer.
Clark GC, Lai A, Agarwal A, Liu Z, et al · · 2023 · cited 1× · PMID 38469569 · DOI 10.3389/fonc.2023.1321326
Ionizing radiation: molecular mechanisms, biological effects, and therapeutic targets.
Wei W, Ren Y, Lan J, Yi J, et al · · 2026 · PMID 41507636 · DOI 10.1186/s43556-025-00358-4

Verify or expand the search:

Other trials of Tetrahydrobiopterin

Trials testing the same drug.

NCT05114226 — A Study for Assessing the Efficacy and Safety of Tetrahydrobiopterin in Radiation-Induced Skin Injury · Phase 1 · unknown

Other recruiting trials for Radiation Enteritis

Currently open trials in the same condition.

NCT07331688 — CMTS0515-auWMT for Radiation Enteritis · Phase 1, PHASE2 · active not recruiting
NCT06617182 — Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury. · Phase 2 · recruiting
NCT03516461 — Fecal Microbiota Transplantation for Radiation Enteritis · NA · recruiting

Other West China Second University Hospital trials

Trials by the same sponsor.

NCT07371182 — Luvometinib in Pediatric SS-LCH With Special-site Single/Multifocal Bone Lesions · NA · recruiting
NCT07511920 — A Multicenter Cohort Study of Duchenne and Becker Muscular Dystrophy in Western Chinese Children · not yet recruiting
NCT07508072 — Comparison of High-Definition Electronic Magnifying Endoscopy With Image-Enhanced Technology Versus Colposcopy in the De · NA · not yet recruiting
NCT07431060 — Modified LCH-III Regimen With or Without Luvometinib for Multisystem Pediatric Langerhans Cell Histiocytosis · NA · recruiting
NCT07201259 — Exploring Gut Microbiome Differences in Female Cancer Patients With Varied Ovarian Function and Fertility Outcomes Follo · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05138887 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by West China Second University Hospital
Last refreshed: 2 March 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05138887.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing