Last reviewed · How we verify
NCT02689245
Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure.
NA trial testing Tenofovir in Acute on Chronic Liver Failure in 64 participants. Completed in 13 March 2018.
13 March 2018
Quick facts
| Lead sponsor | Institute of Liver and Biliary Sciences, India |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 26 February 2016 |
| Primary completion | 13 March 2018 |
| Estimated completion | 13 March 2018 |
| Sites | 1 location across India |
Drugs / interventions tested
- Tenofovir — full drug profile →
- Fecal Microbiota Transplantation (FMT) — full drug profile →
Conditions studied
- Acute on Chronic Liver Failure — all drugs for Acute on Chronic Liver Failure →
Sponsor
Institute of Liver and Biliary Sciences, India
Who can join
Adults 18 to 80, any sex, with Acute on Chronic Liver Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Data for stool microbiome will be collected for all the chronic hepatitis B subjects (pre cirrhotic,compensated,decompensated and reactivation). All the in and out patient with Hepatitis B reactivation will be recruited and randomized into two arms. Group 1 Tenofovir Group 2 Tenofovir with FMT (Fecal Microbiota Transplant). Tenofovir would be given 300 mg once daily FMT through NJ (Naso-Jejunal) tube for 7 days.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Gut microbiome, liver immunology, and liver diseases.
Wang R, Tang R, Li B, Ma X, et al · · 2021 · cited 297× · PMID 33318628 · DOI 10.1038/s41423-020-00592-6 -
Bringing microbiome-drug interaction research into the clinic.
Guthrie L, Kelly L. · · 2019 · cited 48× · PMID 31151933 · DOI 10.1016/j.ebiom.2019.05.009 -
Advances in Fecal Microbiota Transplantation for Gut Dysbiosis-Related Diseases.
Hou S, Yu J, Li Y, Zhao D, et al · · 2025 · cited 34× · PMID 40013938 · DOI 10.1002/advs.202413197 -
Role of Microbiota in Pathogenesis and Management of Viral Hepatitis.
Sehgal R, Bedi O, Trehanpati N. · · 2020 · cited 34× · PMID 32850467 · DOI 10.3389/fcimb.2020.00341 -
Clinical Application and Progress of Fecal Microbiota Transplantation in Liver Diseases: A Review.
Gu X, Lu Q, Zhang C, Tang Z, et al · · 2021 · cited 21× · PMID 34261137 · DOI 10.1055/s-0041-1732319 -
The role of faecal microbiota transplantation: looking beyond <i>Clostridioides difficile</i> infection.
D Goldenberg S, Merrick B, Merrick B. · · 2021 · cited 19× · PMID 33614028 · DOI 10.1177/2049936120981526 -
Gut microbiome and liver diseases.
Xu J, Chen N, Li Z, Liu Y. · · 2025 · cited 6× · PMID 40242515 · DOI 10.1016/j.fmre.2024.09.007
Verify or expand the search:
- PubMed search for NCT02689245
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tenofovir
Trials testing the same drug.
- NCT06295328 — From Fungus to Virus, Investigating the Safety and Efficacy of Terbinafine in Chronic Hepatitis B Patients · Phase 1, PHASE2 · recruiting
- NCT02650271 — Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC · Phase 3 · completed
- NCT04539119 — Entecavir and Tenofovir Versus Entecavir in Lymphoma Patients With Positive HBV DNA · Phase 3 · unknown
- NCT04431375 — Efficacy of Addition of Fecal Microbiota Transplant (FMT) and Plasma Exchange to Tenofovir in Comparison to Monotherapy · NA · unknown
- NCT03986970 — The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention · Phase 2 · completed
Other Institute of Liver and Biliary Sciences, India trials
Trials by the same sponsor.
- NCT07480005 — To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies · recruiting
- NCT07480057 — Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry · recruiting
- NCT07465471 — Carvedilol and Midodrine Versus Carvedilol Alone in Preventing Early Rebleed in Patients With Cirrhosis. · NA · not yet recruiting
- NCT07433881 — Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis · not yet recruiting
- NCT07422948 — Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications · NA · 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 NCT02689245 (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 Institute of Liver and Biliary Sciences, India
- Last refreshed: 23 November 2018
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/NCT02689245.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing