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NCT00939068
A Study of Efficacy and Safety of Telbivudine in Pregnancy for the Prevention of Perinatal Transmission of Hepatitis B Virus Infection
Phase 4 trial testing Telbivudine in Chronic Hepatitis B, Gestation in 180 participants. Status unknown.
1 July 2010
Quick facts
| Lead sponsor | Southeast University, China |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 180 |
| Start date | 1 February 2008 |
| Primary completion | 1 July 2010 |
| Estimated completion | 1 November 2010 |
Drugs / interventions tested
- Telbivudine — full drug profile →
- engineered HB vaccine — full drug profile →
Conditions studied
- Chronic Hepatitis B, Gestation — all drugs for Chronic Hepatitis B, Gestation →
Sponsor
Southeast University, China
Who can join
Adults 20 to 40, female only, with Chronic Hepatitis B, Gestation. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
the intrauterine transmission rate;vertical transmission rate (intrauterine and delivery)
Time frame: 1 month post partum
Sponsor's own description
The purpose of this study is to evaluate the efficacy and safety of Telbivudine in pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00939068
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Telbivudine
Trials testing the same drug.
- NCT02058108 — Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensa · Phase 3 · terminated
- NCT03778567 — Renoprotective Effects of Telbivudine in Chronic Hepatitis B · Phase 4 · completed
- NCT00781105 — Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B · Phase 4 · completed
- NCT00051090 — Treatment of Hepatitis B Virus (HBV) Before Beginning Anti-HIV Drugs in Patients With Both HBV and HIV · NA · withdrawn
Other Southeast University, China trials
Trials by the same sponsor.
- NCT07519512 — Effect of Early Transition to Assisted Ventilation on 28-day Successful Extubation in Critically Ill Patients · NA · recruiting
- NCT06990477 — Effect of EIT-guided PEEP in ARDS Patients With Higher Recruitability · NA · recruiting
- NCT07362537 — Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe ARDS · NA · recruiting
- NCT07327268 — Cyclic On-off Switching of Pulmonary Blood Flow in Moderate to Severe ARDS · not yet recruiting
- NCT07284888 — Practices of Prone Positioning Ventilation in Patients With Moderate-to-Severe ARDS in Intensive Care Units: A Registry- · 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 NCT00939068 (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 Southeast University, China
- Last refreshed: 13 October 2009
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/NCT00939068.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing