Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B
This study is ongoing, but not recruiting participants.
Sponsor:
Beijing YouAn Hospital
Collaborator:
New Discovery LLC
Information provided by (Responsible Party):
Hua Zhang, Beijing YouAn Hospital
ClinicalTrials.gov Identifier:
NCT01743079
First received: December 3, 2012
Last updated: February 8, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to evaluate the efficacy and safety of telbivudine and lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis B Late Pregnancy Transmission Complication |
Drug: Telbivudine Drug: Lamivudine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | The Efficacy and Safety of Telbivudine and Lamivudine Use in Highly Viremic Mothers to Prevent Hepatitis B Transmission |
Resource links provided by NLM:
Further study details as provided by Beijing YouAn Hospital:
Primary Outcome Measures:
- Safety on fetal exposure of telbivudine and lamivudine and vertical transmission rate from mother to child [ Time Frame: From gestation week 26 to postpartum week 52 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- percentage of mothers with serum HBV DNA level reduction, ALT within normal range and HBeAg and/or HBsAg negativity with or without seroconversion [ Time Frame: From gestation week 26 to pastpartume week 52 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 700 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Telbivudine
Mother receives telbivudine 600mg per day. Infant receives standard immunoprophylaxis
|
Drug: Telbivudine
LdT 600mg QD
Other Name: LdT
|
|
Experimental: Lamivudine
Mother receives lamivudine 100mg per day. Infant receives standard immunoprophylaxis.
|
Drug: Lamivudine
LAM 100mg QD
Other Name: LAM
|
|
No Intervention: No antiviral treatment
Mother receives no antiviral treatment. Infant receives standard immunoprophylaxis
|
Detailed Description:
This study enrolls HBV mono-infected pregnant women cohorts managed in outpatient clinics/delivery unit at YouAn Hospital in Beijing. Subjects are prospectively followed from gestation week 26 to postpartum week 52. Treatment naïve mothers with HBV DNA > 6 log10 c/mL and normal ALT are eligible. Mothers with abnormal fetus, cirrhosis or evidence of hepatocellular carcinoma (HCC) are excluded. At gestation week 28, mothers will receive telbivudine (LdT) 600 mg per day or lamivudine (Lam) 100 mg per day until postpartum 4 or no treatment as per their preference. All infants will receive standard immunoprophylaxis. Data is collected from patient records using data extraction forms. Primary endpoints are vertical transmission rates at infants' age of 52 week and the safety of telbivudine or lamivudine use.
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age: 20-40 years old
- HBsAg, HBeAg positive and HBV DNA >6 log10 copies/ml
- Gestational age: 26-28 weeks with normal fetus
- Willing to consent for the study
Exclusion Criteria:
- Elevated ALT
- Antiviral treatment experience patients
- Co-infection with HAV, HCV,HDV, HIV
- Concurrent treatment with immune modulators, cytotoxic drugs, or steroids
- Clinical signs of threatened miscarriage in early pregnancy
- Clinical evidence of cirrhosis and/or hepatocellular carcinoma
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743079
Locations
| China, Beijing | |
| Beijing YouAn Hospital | |
| Beijing, Beijing, China, 100069 | |
Sponsors and Collaborators
Beijing YouAn Hospital
New Discovery LLC
Investigators
| Study Director: | Calvin Pan, MD | Division of Liver Diseases, Mount Sinai School of Medicine, Flushing, NY |
| Principal Investigator: | Hua Zhang, MD | Beijing YouAn Hospital |
More Information
No publications provided
| Responsible Party: | Hua Zhang, Professor, Beijing YouAn Hospital |
| ClinicalTrials.gov Identifier: | NCT01743079 History of Changes |
| Other Study ID Numbers: | 20080810 |
| Study First Received: | December 3, 2012 |
| Last Updated: | February 8, 2013 |
| Health Authority: | China: Food and Drug Administration China: Ethics Committee |
Keywords provided by Beijing YouAn Hospital:
|
Telbivudine Lamivudine safety efficacy pregnancy |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis B, Chronic Pregnancy, Prolonged Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections |
DNA Virus Infections Pregnancy Complications Lamivudine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 19, 2013