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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:
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
  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:

  1. Superinfection with other viruses (hepatitis E, A, D, or C)
  2. other causes of chronic liver failure
  3. coexistent hepatocellular carcinoma (HCC)
  4. portal vein thrombosis
  5. coexistent renal impairment
  6. pregnancy
  7. coinfection with human immunodeficiency virus (HIV)
  8. 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

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 November 20, 2014