Last reviewed · How we verify
NCT06053853
Post Marketing Surveillance of Diphtheria Antitoxin (DAT)
Phase 4 trial testing Diphtheria Antitoxin in Safety Issues in 68 participants. Completed in 23 May 2023.
13 May 2023
Quick facts
| Lead sponsor | PT Bio Farma |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 68 |
| Start date | 31 January 2023 |
| Primary completion | 13 May 2023 |
| Estimated completion | 23 May 2023 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- Diphtheria Antitoxin — full drug profile →
Conditions studied
- Safety Issues — all drugs for Safety Issues →
Sponsor
PT Bio Farma — full company profile →
Who can join
Adults 1 to 70, any sex, with Safety Issues. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to evaluate the safety profile of Diphtheria Antitoxin
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06053853
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Safety Issues
Currently open trials in the same condition.
- NCT06485141 — BeSMART Secure Storage Counseling in the Inpatient Setting · NA · recruiting
- NCT06494527 — A Phase 1 Study to Evaluate the Safety/Tolerability, PK/PD of RG002C0106 Injection in Healthy Adults · Phase 1 · active not recruiting
- NCT06189170 — Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients · EARLY_PHASE1 · recruiting
- NCT06509490 — NKG2D CAR-T(KD-025) in the Treatment of Advanced NKG2DL+ Solid Tumors · NA · recruiting
- NCT06498167 — Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib) · recruiting
Other PT Bio Farma trials
Trials by the same sponsor.
- NCT06921460 — Long-Term Protection of Vi Antibodies Induced by Bio TCV in Indonesian Population Compared to PQed TCV · not yet recruiting
- NCT06690515 — Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in · Phase 1, PHASE2 · not yet recruiting
- NCT06690502 — Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination · completed
- NCT05933278 — Homologous Booster Study of COVID-19 Protein Subunit Recombinant Vaccine · Phase 2 · completed
- NCT06114641 — Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients · Phase 4 · completed
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 NCT06053853 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PT Bio Farma
- Last refreshed: 18 November 2023
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/NCT06053853.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing