Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels

NCT01337791 | Completed Phase 4 DMC

• 1 other identifier: H200804IRB
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Telbivudine reduces DNA and normalizes alanine aminotransferase levels (ALT) in chronic hepatitis B patients with few adverse effects, but its use during pregnancy has not been explored. In this open-label, prospective study from the second trimester to post-partum week 28. This trial is to study the efficacy, safety and tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women with high level of serum HBV DNA and elevated alanine aminotransferase levels.

Conditions

Chronic Hepatitis B; Pregnancy Complications; High Viral Load; Elevated Alanine Aminotransferase Levels

Keywords

chronic hepatitis B; hepatitis B virus; perinatal transmission; Telbivudine

Outcome Measures

Primary Outcomes (1)

• The efficacy of Telbivudine treatment (DNA reduction, ALT normalization, and infants' immunoprophylaxis failure) and safety

  From late pregnancy to 28 weeks of postpartum

Secondary Outcomes (1)

• Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg

  From late pregnancy to 28 weeks of postpartum

Study Arms (2)

control

NO INTERVENTION

Drug: Telbivudine treatment

telbivudine

NO INTERVENTION

Interventions

Telbivudine treatment DRUG

Two arms in this study, One is Telbivudine 600 mg by mouth daily from late pregnancy to 28 weeks of post partum. Another arm is clinical observation only without telbivudine treatment

control

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age between 20-40 years
• gestational age between 12-30 weeks
• serum HBsAg and HBeAg positivity
• HBV DNA levels \>6log10 copies/mL
• ALT \>1x ULN (40 IU/mL) and \< 10x ULN.

You may not qualify if:

• co-infection with hepatitis A, C, D, E or HIV
• evidence of hepatocellular carcinoma; decompensated liver disease or significant renal, cardiovascular, respiratory or neurological co-morbidity
• concurrent treatment with immune-modulators, cytotoxic drugs, or steroids
• clinical signs of threatened miscarriage in early pregnancy
• evidence of fetal deformity by 3-dimensional ultrasound examination
• the biological father of the child had CHB

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University

Nanjing, Jiangsu, 210003, China

Location

Related Publications (1)

• Pan CQ, Han GR, Jiang HX, Zhao W, Cao MK, Wang CM, Yue X, Wang GJ. Telbivudine prevents vertical transmission from HBeAg-positive women with chronic hepatitis B. Clin Gastroenterol Hepatol. 2012 May;10(5):520-6. doi: 10.1016/j.cgh.2012.01.019. Epub 2012 Feb 14.

  PMID: 22343511 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic; Pregnancy Complications; Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 19, 2011
• Study Start: August 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 19, 2011

Record last verified: 2011-04

Locations

CN (1)