Back to resultsTo Compare the Efficacy of Combined Tenofovir Plus Telbivudine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B
Primary Purpose
Spontaneous Reactivation of Hepatitis B
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Tenofovir + Telbivudine
Tenofovir
Sponsored by
About this trial
This is an interventional treatment trial for Spontaneous Reactivation of Hepatitis B
Eligibility 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.
Sites / Locations
- Institute of Liver & Biliary Sciences (ILBS)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tenofovir + Telbivudine
Tenofovir
Arm Description
Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
In tenofovir arm subjects will receive tenofovir (300 mg) once daily.
Outcomes
Primary Outcome Measures
Survival
Secondary Outcome Measures
Reduction in HBV DNA.
Drug(s) related adverse effects/ side effects
Improvement in CTP and MELD scores
Alteration of renal functions
Full Information
NCT ID
NCT01732224
First Posted
November 19, 2012
Last Updated
March 22, 2016
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT01732224
Brief Title
To Compare the Efficacy of Combined Tenofovir Plus Telbivudine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Reactivation of Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tenofovir + Telbivudine
Arm Type
Experimental
Arm Description
Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
Arm Title
Tenofovir
Arm Type
Active Comparator
Arm Description
In tenofovir arm subjects will receive tenofovir (300 mg) once daily.
Intervention Type
Drug
Intervention Name(s)
Tenofovir + Telbivudine
Intervention Description
Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
Intervention Type
Drug
Intervention Name(s)
Tenofovir
Intervention Description
In tenofovir arm subjects will receive tenofovir (300 mg) once daily.
Primary Outcome Measure Information:
Title
Survival
Time Frame
1 and 3 months
Secondary Outcome Measure Information:
Title
Reduction in HBV DNA.
Time Frame
7 days, 15 days, 1 month and 3 month
Title
Drug(s) related adverse effects/ side effects
Time Frame
1 and 3 months
Title
Improvement in CTP and MELD scores
Time Frame
1 and 3 months
Title
Alteration of renal functions
Time Frame
1 and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiv Kumar Sarin, DM
Organizational Affiliation
Institute of Liver & Biliary Sciences (ILBS).
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences (ILBS)
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Learn more about this trial
To Compare the Efficacy of Combined Tenofovir Plus Telbivudine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B
We'll reach out to this number within 24 hrs