Chronic Hepatitis BPhase 4NCT01337791
Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels
A Phase 4 study testing Telbivudine treatment in people with Chronic Hepatitis B and Pregnancy Complications, run by Southeast University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Chronic Hepatitis B, Pregnancy Complications, High Viral Load
- What is being tested?
- Telbivudine treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- Aug 2008to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University
Nanjing, Jiangsu, 210003
About this study
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
- Being tested
- Telbivudine treatment
- Keywords
- chronic hepatitis B, hepatitis B virus, perinatal transmission, Telbivudine
- Medical subject headings
- Hepatitis B, Chronic, Pregnancy Complications, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telbivudine treatmentDrug
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
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described Receives: Drug: Telbivudine treatment |
| telbivudine | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of Telbivudine treatment (DNA reduction, ALT normalization, and infants' immunoprophylaxis failure) and safety
Measured: From late pregnancy to 28 weeks of postpartum
Secondary outcomes (1)
Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg
Measured: From late pregnancy to 28 weeks of postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startAug 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337791
- Sponsor's protocol ID
- H200804IRB
- Status last verified
- Apr 2011
- First submitted
- 15 Apr 2011
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22343511
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels
- ClinicalTrials.gov ID
- NCT01337791
- Acronym / sponsor ID
- H200804IRB
- Conditions
- Chronic Hepatitis B, Pregnancy Complications, High Viral Load, Elevated Alanine Aminotransferase Levels
- Keywords
- chronic hepatitis B, hepatitis B virus, perinatal transmission, Telbivudine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | Drug: Telbivudine treatment |
| telbivudine | No intervention | – |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telbivudine treatmentTwo 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 | Drug | control |
Primary outcome
The efficacy of Telbivudine treatment (DNA reduction, ALT normalization, and infants' immunoprophylaxis failure) and safety
Time frame: From late pregnancy to 28 weeks of postpartum
1 secondary outcome
Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg
Time frame: From late pregnancy to 28 weeks of postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
- Derived from this study: PubMed 22343511Pan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telbivudine treatment in people with Chronic Hepatitis B and Pregnancy Complications, run by Southeast University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of Telbivudine treatment (DNA reduction, ALT normalization, and infants' immunoprophylaxis failure) and safety (time frame: From late pregnancy to 28 weeks of postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01337791, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2011.