To Compare the Efficacy of Combined Tenofovir Plus Telbivudine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B
This study is currently recruiting participants.
(see Contacts and Locations)
Verified November 2012 by Institute of Liver and Biliary Sciences, India
Sponsor:
Institute of Liver and Biliary Sciences, India
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01732224
First received: November 19, 2012
Last updated: May 7, 2014
Last verified: November 2012
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Purpose
The relevant data will be prospectively collected included patient demographics, clinical, all laboratory variables including virological tests, genotyping by direct sequencing, abdominal ultrasound, and upper gastrointestinal (GI) endoscopy. Trans jugular liver biopsy (TJLB) and hepatic venous pressure gradient (HVPG) will be done in patients when it was not evident whether the underlying liver disease was chronic based on clinical, biochemical, radiological investigations, and upper GI endoscopy. Severity of the liver disease will be assessed by Child-Turcotte Pugh score (CTP) and model for end stage liver disease (MELD) score.
| Condition | Intervention |
|---|---|
|
Spontaneous Reactivation of Hepatitis B |
Drug: Tenofovir + Telbivudine Drug: Tenofovir |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Randomized Controlled Study to Compare the Efficacy of Combined Tenofovir Plus Telbuvidine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B. |
Resource links provided by NLM:
Further study details as provided by Institute of Liver and Biliary Sciences, India:
Primary Outcome Measures:
- Survival [ Time Frame: 1 and 3 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Reduction in HBV DNA. [ Time Frame: 7 days, 15 days, 1 month and 3 month ] [ Designated as safety issue: No ]
- Drug(s) related adverse effects/ side effects [ Time Frame: 1 and 3 months ] [ Designated as safety issue: Yes ]
- Improvement in CTP and MELD scores [ Time Frame: 1 and 3 months ] [ Designated as safety issue: No ]
- Alteration of renal functions [ Time Frame: 1 and 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tenofovir + Telbivudine
Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
|
Drug: Tenofovir
In tenofovir arm subjects will receive tenofovir (300 mg) once daily.
|
|
Active Comparator: Tenofovir
In tenofovir arm subjects will receive tenofovir (300 mg) once daily.
|
Drug: Tenofovir + Telbivudine
Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Reactivation of CHB characterized by a rise in ALT level >5 times upper limit of normal along with HBV DNA level >10^5 copies/ mL (> 1.8 X 10^4 IU/mL).
Exclusion Criteria:
- Superinfection with other viruses (hepatitis E, A, D, or C)
- other causes of chronic liver failure
- coexistent hepatocellular carcinoma (HCC)
- portal vein thrombosis
- coexistent renal impairment
- pregnancy
- coinfection with human immunodeficiency virus (HIV)
- patients who had received a previous course of any antiviral, immunomodulator or cytotoxic/immunosuppressive therapy for chronic hepatitis or other illness within at least the preceding 12 months.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732224
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732224
Contacts
| Contact: Dr Ankur Jindal, MD | 9582670984 | ankur.jindal3@gmail.com |
Locations
| India | |
| Institute of Liver & Biliary Sciences (ILBS) | Recruiting |
| New Delhi, Delhi, India, 110070 | |
| Contact: Dr Ankur Jindal, MD +91-9582670984 ankur.jindal3@gmail.com | |
| Contact: Dr Ankit Bhardwaj 011-46300000 ext 1032 bhardwaj.ankit3@gmail.com | |
| Principal Investigator: Shiv Kumar Sarin | |
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
| Principal Investigator: | Shiv Kumar Sarin, DM | Institute of Liver & Biliary Sciences (ILBS). |
More Information
No publications provided
| Responsible Party: | Institute of Liver and Biliary Sciences, India |
| ClinicalTrials.gov Identifier: | NCT01732224 History of Changes |
| Other Study ID Numbers: | ILBS-HBV Reactivation-01 |
| Study First Received: | November 19, 2012 |
| Last Updated: | May 7, 2014 |
| Health Authority: | India: Ministry of Health |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B DNA Virus Infections Digestive System Diseases Enterovirus Infections Hepadnaviridae Infections Hepatitis, Viral, Human Liver Diseases Picornaviridae Infections RNA Virus Infections Virus Diseases Telbivudine |
Tenofovir Tenofovir disoproxil Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on February 26, 2015