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NCT03688191: SSCI
Study of Sirolimus in CTD-TP in China
Phase 4 trial testing Sirolimus in Connective Tissue Diseases in 20 participants. Status unknown.
31 December 2018
Quick facts
| Lead sponsor | Peking Union Medical College Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 21 September 2017 |
| Primary completion | 31 December 2018 |
| Estimated completion | 30 September 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sirolimus (sirolimus) — full drug profile →
Conditions studied
- Connective Tissue Diseases — all drugs for Connective Tissue Diseases →
- Thrombocytopenia — all drugs for Thrombocytopenia →
Sponsor
Peking Union Medical College Hospital
Who can join
Adults 16 to 80, any sex, with Connective Tissue Diseases or Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
We have designed a single-arm, open-label study of sirolimus in Chinese patients with refractory CTD-TP unresponsive to, or intolerant of, conventional medications at Peking Union Medical College Hospital (PUMCH). Patients received oral sirolimus at a starting dose of 2 mg per day for 3 days and a sequential dose of 1mg per day, with dose adjusted according to tolerance and to maintain a therapeutic range of 6-15 ng/mL. Patients were treated with sirolimus for more than 6 months. Safety outcomes and the efficacy endpoints were assessed in all patients who received at least one dose of treatment.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Sirolimus for patients with connective tissue disease-related refractory thrombocytopenia: a single-arm, open-label clinical trial.
Wu C, Wang Q, Xu D, Li M, et al · · 2021 · cited 20× · PMID 33200217 · DOI 10.1093/rheumatology/keaa645 -
Advances in the regulatory mechanisms of mTOR in necroptosis.
Xie Y, Zhao G, Lei X, Cui N, et al · · 2023 · cited 12× · PMID 38164133 · DOI 10.3389/fimmu.2023.1297408
Verify or expand the search:
- PubMed search for NCT03688191
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Connective Tissue Diseases
Currently open trials in the same condition.
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- NCT06574581 — ADSCs Therapy in Patients With CTD-ILD · Phase 1, PHASE2 · recruiting
- NCT06104228 — 129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH) · Phase 2 · recruiting
Other Peking Union Medical College Hospital trials
Trials by the same sponsor.
- NCT07466251 — PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke · Phase 4 · not yet recruiting
- NCT06743321 — Speech-to-speech Voice-cloning Care (SVCC) to Improve ICU-acquired Anxiety for Critically Ill Patients · NA · not yet recruiting
- NCT07590336 — 68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma · Phase 1, PHASE2 · not yet recruiting
- NCT07515976 — Mapping of Genomic Structural Variations in Major Birth Defects · not yet recruiting
- NCT07386756 — Early Precise Identification and Intervention Strategies for Individuals at High Risk of Prediabetes · 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)
- Trial protocol + status: ClinicalTrials.gov NCT03688191 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 Peking Union Medical College Hospital
- Last refreshed: 17 April 2019
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/NCT03688191.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing