Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus
This study is currently recruiting participants.
Verified March 2012 by New Discovery LLC
Sponsor:
New Discovery LLC
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
New Discovery LLC
ClinicalTrials.gov Identifier:
NCT01488526
First received: November 30, 2011
Last updated: October 26, 2012
Last verified: March 2012
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Purpose
Immunoprophylaxis failure of Hepatitis B (HBV) leading to vertical transmission remains a concern and has been reported in approximately 8-15% of infants born to HBeAg positive mothers with high levels of HBV DNA. Maternal HBV DNA > 6log10 copies/mL is the major risk for the mother-to-child transmission. Prior studies have shown that antiviral therapy including lamivudine or telbivudine use during late pregnancy can safely reduce the rate of vertical transmission in this special population compared to untreated patients.
Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and normalizes serum ALT in chronic hepatitis B patients (CHB) with few adverse effects. Two aspects on tenofovir use in pregnancy will be evaluated prospectively in this study:
- The data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA > 6log10 copies/mL during late pregnancy and infants
- Its efficacy in the reduction of HBV vertical transmission rate
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B Infection Chronic Infection Viremia |
Drug: TDF treatment |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Tenofovir Disoproxil Fumarate in Late Pregnancy to Prevent Mother to Child Transmission of Hepatitis B Virus: A Multi-Center Prospective, Randomized, Open-Label Study |
Resource links provided by NLM:
Drug Information available for:
Tenofovir
Tenofovir Disoproxil Fumarate
Recombinant Hepatitis B vaccine
Hepatitis A Vaccines
U.S. FDA Resources
Further study details as provided by New Discovery LLC:
Primary Outcome Measures:
- Assessment of the safety of TDF, measure the number of participants and paired infants with adverse events [ Time Frame: From the date of randomization until 28 weeks of postpartum. ] [ Designated as safety issue: Yes ]
- Measure the number of infants who have HBV infection at the age of 28 weeks [ Time Frame: From the date of birth to age of 28 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Measure the number of patients with ALT normalization at the end of the study compared to the baseline [ Time Frame: From the date of randomization until 28 weeks of postpartum. ] [ Designated as safety issue: Yes ]
- Measure maternal HBV DNA reduction during the study period when compared to the baseline [ Time Frame: From the date of randomization until 28 weeks of postpartum. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: HBIG, HB vaccine
Provide standard of care to mothers and standard immunoprophylaxis to their infants
|
|
|
Experimental: TDF treatment arm
tenofovir from 30-32 weeks of pregnancy to the week 4 of postpartum for mothers and standard immunoprophylaxis to their infants
|
Drug: TDF treatment
About 100 mothers treated with tenofovir from 30-32 weeks of pregnancy to the week 4 of postpartum, then observed to the end of the study at post-partum week 28, paired infants received standard HBV prophylaxis.
Other Name: Viread, Tenofovir, TDF, Hepatitis B-IgG, Hepatitis B vaccine
|
Detailed Description:
Eligible mothers will be randomized (1:1)to either TDF-treated group or untreated group with about 100 subjects in each arm. The treatment group will receive TDF starting at week 30-32 of gestation until week 4 post-partum; follow up will continue until post-partum of week 28 and infants age of 28 weeks. Untreated group will receive the standard of care with similar follow-up schedule as the treatment group
Eligibility| Ages Eligible for Study: | 20 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- documented CHB infection with HBsAg positive > 6 months
- HBeAg+ CHB pregnant women
- gestational age between 30-32 weeks
- HBV DNA > 6 log10 copies/mL
- both mother and father of the child are willing to consent for the study
Major Exclusion Criteria:
- co-infection with hepatitis A, C, D, E,HIV or STD
- decompensated liver disease or significant co-morbidity
- history of abortion, or diagnosis of fetal defect, or congenital malformation in prior pregnancy
- antiviral used within six months prior to this pregnancy, or history of renal or tubular function impairment due to adefovir.
- requirement for other medication during pregnancy to manage other chronic disease(s) or concurrent treatment with immune-modulators, cytotoxic drugs, or steroids
- the biological father of the child had CHB
- clinical signs of threatened miscarriage in early pregnancy
- evidence of hepatocellular carcinoma
- maternal ALT > or = 5 x ULN U/mL, or Total Bilirubin > or = 2, or GFR < 100, or Albumin < 25 g/L
- evidence of fetal deformity by ultrasound examination
- patient is participating other clinical study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488526
Contacts
| Contact: Calvin Q Pan, MD | +01-7188887728 | cpan11355@yahoo.com |
| Contact: Frank Huang, MD | +86-13533051208 | frankhuangyujun@gmail.com |
Locations
| China, Chongqing | |
| Southwest Hospital | Recruiting |
| Chongqing, Chongqing, China, 400038 | |
| Contact: Yuming Wang, MD 023-65334998 wym417@163.com | |
| Contact: Hongfei Huang, MD 13983068253 huanghongfei1987@126.com | |
| Principal Investigator: Yuming Wang, MD | |
| Sub-Investigator: Junnan Li, MD | |
| China, Hebei | |
| The Fifth Hospital of Shijiazhuang | Recruiting |
| Shijiazhuang, Hebei, China, 050021 | |
| Contact: Er Hei Dai, MD +86-13323119296 daieh2008@yahoo.com.cn | |
| Contact: Baoshen Zhu, MD +86-13331389593 | |
| Principal Investigator: Er Hei Dai, MD | |
| Sub-Investigator: Baoshen Zhu, MD | |
| China, Henan | |
| Nanyang Central Hospital | Recruiting |
| Nanyang, Henan, China, 473000 | |
| Contact: Huaihong Zhang, MD 0377-61660525 zhang1958@126.com | |
| Contact: Li Zhang, MD 0377-61660523 zhangli870920@126.com | |
| Principal Investigator: Huaihong Zhang, MD | |
| Sub-Investigator: Li Zhang, MD | |
| China, Jiangsu | |
| The Second Affiliated Hospital of the Southeast University | Recruiting |
| Nan Jing, Jiangsu, China, 210003 | |
| Contact: Guo Rong Han, MD +86-13851623507 hgr518@163.com | |
| Contact: Hong Xiu Jiang, MD +86-025-83626372 | |
| Principal Investigator: Guo Rong Han, MD | |
| Sub-Investigator: Wei Zhao, MD | |
| China, Jilin | |
| Hepatobiliary Disease Hospital of Jilin Province | Recruiting |
| Chang Chun, Jilin, China, 130062 | |
| Contact: Shuqin Zhang, MD +86-13894892233 Zhangshuqin2009@126.com | |
| Contact: Wen Jing Zhao, MD +86-13234454220 | |
| Principal Investigator: Shuqin Zhang, MD | |
| Sub-Investigator: Chang Han, MD | |
Sponsors and Collaborators
New Discovery LLC
Gilead Sciences
Investigators
| Study Chair: | Calvin Q Pan, MD | Mount Sinai School of Medicine, New York, USA |
| Study Director: | Zhong Ping Duan, MD | Capital Medical University |
| Principal Investigator: | Shuqin Zhang, MD | Hepatobiliary Disease Hospital of Jilin Province, Jilin, China |
| Principal Investigator: | Er Hei Dai, MD | The Fifth Hospital of Shijiazhuang, Shijiazhuang, Hebei, China |
| Principal Investigator: | Gao Rong Han, MD | The Second Affiliated Hospital of the Southeast University, Nanjing, China |
| Principal Investigator: | Huaihong Zhang, MD | Nanyang Central Hospital, Nanyang, Henan, China |
| Principal Investigator: | Yuming Wang, MD | Southwest Hospital, Chongqing, Chongqing, China |
| Principal Investigator: | Zheng Zeng, MD, PhD | New Discovery LLC |
More Information
No publications provided
| Responsible Party: | New Discovery LLC |
| ClinicalTrials.gov Identifier: | NCT01488526 History of Changes |
| Other Study ID Numbers: | IN-US 174-0174 |
| Study First Received: | November 30, 2011 |
| Last Updated: | October 26, 2012 |
| Health Authority: | China: Ethics Committee |
Keywords provided by New Discovery LLC:
|
Hepatitis B Vertical transmission Pregnancy Antiviral treatment |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Viral, Human Viremia Liver Diseases Digestive System Diseases Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Sepsis Systemic Inflammatory Response Syndrome |
Inflammation Pathologic Processes Tenofovir Tenofovir disoproxil 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 23, 2013