Back to resultsTDF and LdT in Immune-tolerant CHB Patients Awaiting Assisted Reproduction
Primary Purpose
Hepatitis B, Chronic
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Tenofovir and telbivudine
Tenofovir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic
Eligibility Criteria
Inclusion Criteria:
- aged 18-45 years old with artificial reproductive needs
- Liver function (ALT) <40U/L for male and <30 for female
- HBV-DNA> 10e+5
- HBVeAg +
- History> 0.5 years
Exclusion Criteria:
- Cirrhosis
- Combined with other liver diseases such as autoimmune liver disease, alcoholic liver disease, fatty liver
- Liver or other parts of malignancies
- Bilirubin> 17.1
- GGT> 2ULN
- Liver transplant patients
- combined HCV, HDV, HIV infection
- A history of anti-HBV drug resistance
- History of habitual abortion
- previous fetal malformation history
- CRP> 3.0ng / ml
- Uncontrolled hypertension
- Proteinuria or Calculated creatinine clearance < 70 mL/min
- Heart failure or acute coronary syndrome
- Coagulopathy
- Drug or alcohol addiction
- Hyperlipidemia LDL> 4.6 or TG> 2.0
- Alphafetoprotein > 50 ng/mL
- Received interferon (pegylated or not) therapy within 6 months of the screening visit
- Evidence of hepatocellular carcinoma
- Received solid organ or bone marrow transplantation
- Was currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents
- Known hypersensitivity to the study drugs, the metabolites, or formulation excipients
Sites / Locations
- Fuzhou General Hospital, Xiamen Univ
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
COM
TDF
Arm Description
COM group receives combination therapy of tenofovir and telbivudine (TDF and LdT) for at least 48 weeks
TDF group receives single therapy of tenofovir (TDF) for at least 48 weeks
Outcomes
Primary Outcome Measures
Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12
Secondary Outcome Measures
Percentage of Participants With HBV DNA < 500 Copies/mL at Week 24, 36 and 48
Number of Participants With Normal Alanine Aminotransferase (ALT) at Week 12, 24, 36 and 48
Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 12, 24, 36 and 48
Number of Participants With Seroconversion to Antibody Against HBeAg (AntiHBe) at Week 12, 24, 36 and 48
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12, 24, 36 and 48
Number of Participants With Seroconversion to Antibody to HBsAg (AntiHBs) at Week 12, 24, 36 and 48
Occurrence of HBV Resistance Mutations
off-treatment recurrence of HBV
Down syndrome Occurrence
Fetal Malformations Occurrence
Full Information
NCT ID
NCT02338674
First Posted
January 11, 2015
Last Updated
September 21, 2018
Sponsor
Fuzhou General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02338674
Brief Title
TDF and LdT in Immune-tolerant CHB Patients Awaiting Assisted Reproduction
Official Title
Combination Therapy of Tenofovir and Telbivudine in Immune-tolerant Patients With Chronic Hepatitis B Awaiting Assisted Reproduction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fuzhou General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Immune-tolerant patients with chronic hepatitis B (CHB) awaiting assisted reproduction (AR) are required to initiate antiviral therapy due to laboratory safety. Additionally, rapid virus elimination is suggested to faciliate timely performance of AR. However, no consensus is reached regarding the antiviral therapy in this group. This study aimed to explore the efficacy and safety of tenofovir (TDF) and telbivudine (LdT) in this population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COM
Arm Type
Experimental
Arm Description
COM group receives combination therapy of tenofovir and telbivudine (TDF and LdT) for at least 48 weeks
Arm Title
TDF
Arm Type
Active Comparator
Arm Description
TDF group receives single therapy of tenofovir (TDF) for at least 48 weeks
Intervention Type
Drug
Intervention Name(s)
Tenofovir and telbivudine
Other Intervention Name(s)
combination therapy
Intervention Description
tenofovir and telbivudine administered at least 48 weeks
Intervention Type
Drug
Intervention Name(s)
Tenofovir
Other Intervention Name(s)
single therapy
Intervention Description
tenofovir administered at least 48 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With HBV DNA < 500 Copies/mL at Week 24, 36 and 48
Time Frame
Week 24, 36 and 48
Title
Number of Participants With Normal Alanine Aminotransferase (ALT) at Week 12, 24, 36 and 48
Time Frame
Week 12, 24, 36 and 48
Title
Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 12, 24, 36 and 48
Time Frame
Week 12, 24, 36 and 48
Title
Number of Participants With Seroconversion to Antibody Against HBeAg (AntiHBe) at Week 12, 24, 36 and 48
Time Frame
Week 12, 24, 36 and 48
Title
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12, 24, 36 and 48
Time Frame
Week 12, 24, 36 and 48
Title
Number of Participants With Seroconversion to Antibody to HBsAg (AntiHBs) at Week 12, 24, 36 and 48
Time Frame
Week 12, 24, 36 and 48
Title
Occurrence of HBV Resistance Mutations
Time Frame
Baseline to Week 48
Title
off-treatment recurrence of HBV
Time Frame
Week 72 to 96
Title
Down syndrome Occurrence
Time Frame
week 13 of pregnancy
Title
Fetal Malformations Occurrence
Time Frame
week 26 of pregnancy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 18-45 years old with artificial reproductive needs
Liver function (ALT) <40U/L for male and <30 for female
HBV-DNA> 10e+5
HBVeAg +
History> 0.5 years
Exclusion Criteria:
Cirrhosis
Combined with other liver diseases such as autoimmune liver disease, alcoholic liver disease, fatty liver
Liver or other parts of malignancies
Bilirubin> 17.1
GGT> 2ULN
Liver transplant patients
combined HCV, HDV, HIV infection
A history of anti-HBV drug resistance
History of habitual abortion
previous fetal malformation history
CRP> 3.0ng / ml
Uncontrolled hypertension
Proteinuria or Calculated creatinine clearance < 70 mL/min
Heart failure or acute coronary syndrome
Coagulopathy
Drug or alcohol addiction
Hyperlipidemia LDL> 4.6 or TG> 2.0
Alphafetoprotein > 50 ng/mL
Received interferon (pegylated or not) therapy within 6 months of the screening visit
Evidence of hepatocellular carcinoma
Received solid organ or bone marrow transplantation
Was currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents
Known hypersensitivity to the study drugs, the metabolites, or formulation excipients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongliangli Li, Dr.
Organizational Affiliation
Department of Hepatobiliary Disease
Official's Role
Study Chair
Facility Information:
Facility Name
Fuzhou General Hospital, Xiamen Univ
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
12. IPD Sharing Statement
Learn more about this trial
TDF and LdT in Immune-tolerant CHB Patients Awaiting Assisted Reproduction
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