Hepatitis B, ChronicNCT02510963
Optimal Time for Tenofovir Treatment of Anti-Hepatitis B Virus (HBV) During the Pregnancy
A study testing Tenofovir Disoproxil Fumarate in people with Hepatitis B, Chronic, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
To determine the optimal time for the Tenofovir treatment of anti-Hepatitis B Virus (HBV) during the pregnancy among women with chronic HBV infection and high HBV DNA load. This is a randomized, open-label, three-arms, parallel-controlled clinical trial. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Tenofovir Disoproxil Fumarate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Aug 2017
- Phase
- Interventional
- 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
- Women between 20 and 40 years old
- Have had HBsAg positive in serum greater than 6 months
- HBV DNA load>10**6 IU/ml
- Gestation week<24 weeks
- Normal liver function
- Able to comprehend and willing to sign the informed consent form
Who cannot join
- Combined with following infections: hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV) and human immunodeficiency virus (HIV)
- Got antiviral treatments before 24 weeks of Gestation
- Got immunosuppressor treatment and/or steroids
- Got diagnosis of cirrhosis,hepatocellular carcinoma or severe hepatitis B
- Got serious obstetric complications
- Got evidence of fetal deformity diagnosed by four-dimensional color Doppler ultrasound examination
- Biological father of infant had HBV infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061
Tianyan Chen, 86-18991232530
About this study
Official title: An Open-label, Randomized, Controlled Clinical Trial to Determine the Optimal Time for Tenofovir of Anti-HBV Treatment During the Pregnancy Among Chronic HBV-infected Pregnant Women With Normal Liver Function
To determine the optimal time for the Tenofovir treatment of anti-Hepatitis B Virus (HBV) during the pregnancy among women with chronic HBV infection and high HBV DNA load. This is a randomized, open-label, three-arms, parallel-controlled clinical trial. Pregnant women with high HBV load and normal liver function will be treated with tenofovir during the middle or late stage of pregnancy, started from 24th gestational week, 28th gestational week and 32th gestational week through 1 month postpartum, respectively. The HBV DNA load at 40th gestational week of mothers, the intrauterine HBV infection rate of infants will be compared across the three groups.
Read the detailed description
Tenofovir Disoproxil Fumarate is a American Food and Drug Administration (FDA) pregnancy class B drug. To determine the optimal time for the tenofovir treatment during the pregnancy among women with chronic HBV infection and high HBV DNA load. Pregnant women with high HBV DNA load and normal liver function at second trimester will be randomized into three treatment groups at the 20th week of gestation and treated with tenofovir from 24 weeks, 28 weeks and 32 weeks to 1 month postpartum, respectively. The blood will be drawn at 24 weeks, 28 weeks, 32 weeks, 36 weeks and the delivery, respectively and the HBV DNA load and liver functions will be tested. The status of HBV infection for infants will be observed at 1st month, 7th month and 12th month after the babies were delivered. The HBV DNA load at 40th gestational week of mothers, the intrauterine HBV infection rate of infants and safety outcomes will be compared across the three groups.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Tenofovir Disoproxil Fumarate
- Keywords
- Vertical infection transmission, Tenofovir
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil FumarateDrug
Also called Tenofovir
Use Tenofovir at 24week of gestation
Tenofovir Disoproxil FumarateDrug
Also called Tenofovir
Use Tenofovir at 28week of gestation
Tenofovir Disoproxil FumarateDrug
Also called Tenofovir
Use Tenofovir at 32week of gestation
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir 24 week | Experimental | Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 24 weeks of gestation to 1 month postpartum Receives: Drug: Tenofovir Disoproxil Fumarate |
| Tenofovir 28 week | Experimental | Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 28 weeks of gestation to 1 month postpartum Receives: Drug: Tenofovir Disoproxil Fumarate |
| Tenofovir 32 week | Active comparator | Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 32 weeks of gestation to 1 month postpartum Receives: Drug: Tenofovir Disoproxil Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV DNA load in serum
the difference in the percentage of mothers whose HBV DNA load in serum are less than 10*2 IU/ml at delivery among the groups
Measured: 40 weeks, from randomization to delivery
Secondary outcomes (3)
Intrauterine HBV infection rate of infants
Intrauterine HBV infection rate of infants at the 12th months after delivery
Measured: 12 months, from delivery to one-year birth date
Change in HBV DNA load
Total change in HBV DNA load from the start of treatment to the delivery was compared across the three groups
Measured: 40 weeks, from randomization to delivery
Change in hepatitis B e antigen (HBeAg) titer
Total change in HBeAg titer from the start of treatment to the delivery was compared across the three groups
Measured: 40 weeks, from randomization to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tianyan Chen, MD,PHD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510963
- Sponsor's protocol ID
- XJTU1AHCR2014-013
- Status last verified
- Aug 2016
- First submitted
- 22 Jul 2015
- Last updated
- 10 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Controlled Clinical Trial to Determine the Optimal Time for Tenofovir of Anti-HBV Treatment During the Pregnancy Among Chronic HBV-infected Pregnant Women With Normal Liver Function
- ClinicalTrials.gov ID
- NCT02510963
- Acronym / sponsor ID
- XJTU1AHCR2014-013
- Conditions
- Hepatitis B, Chronic
- Keywords
- Vertical infection transmission, Tenofovir
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 29 Jul 2015 (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.
To determine the optimal time for the Tenofovir treatment of anti-Hepatitis B Virus (HBV) during the pregnancy among women with chronic HBV infection and high HBV DNA load. This is a randomized, open-label, three-arms, parallel-controlled clinical trial. Pregnant women with high HBV load and normal liver function will be treated with tenofovir during the middle or late stage of pregnancy, started from 24th gestational week, 28th gestational week and 32th gestational week through 1 month postpartum, respectively. The HBV DNA load at 40th gestational week of mothers, the intrauterine HBV infection rate of infants will be compared across the three groups.
Detailed description
Tenofovir Disoproxil Fumarate is a American Food and Drug Administration (FDA) pregnancy class B drug. To determine the optimal time for the tenofovir treatment during the pregnancy among women with chronic HBV infection and high HBV DNA load. Pregnant women with high HBV DNA load and normal liver function at second trimester will be randomized into three treatment groups at the 20th week of gestation and treated with tenofovir from 24 weeks, 28 weeks and 32 weeks to 1 month postpartum, respectively. The blood will be drawn at 24 weeks, 28 weeks, 32 weeks, 36 weeks and the delivery, respectively and the HBV DNA load and liver functions will be tested. The status of HBV infection for infants will be observed at 1st month, 7th month and 12th month after the babies were delivered. The HBV DNA load at 40th gestational week of mothers, the intrauterine HBV infection rate of infants and safety outcomes will be compared across the three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tenofovir 24 week | Experimental | Drug: Tenofovir Disoproxil FumaratePregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 24 weeks of gestation to 1 month postpartum |
| Tenofovir 28 week | Experimental | Drug: Tenofovir Disoproxil FumaratePregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 28 weeks of gestation to 1 month postpartum |
| Tenofovir 32 week | Active comparator | Drug: Tenofovir Disoproxil FumaratePregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 32 weeks of gestation to 1 month postpartum |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women between 20 and 40 years old
- Have had HBsAg positive in serum greater than 6 months
- HBV DNA load>10**6 IU/ml
- Gestation week<24 weeks
- Normal liver function
Key exclusion criteria (7 listed)
- Combined with following infections: hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV) and human immunodeficiency virus (HIV)
- Got antiviral treatments before 24 weeks of Gestation
- Got immunosuppressor treatment and/or steroids
- Got diagnosis of cirrhosis,hepatocellular carcinoma or severe hepatitis B
- Got serious obstetric complications
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 |
|---|---|---|
| Tenofovir Disoproxil FumarateAlso: TenofovirUse Tenofovir at 24week of gestation | Drug | Tenofovir 24 week |
| Tenofovir Disoproxil FumarateAlso: TenofovirUse Tenofovir at 28week of gestation | Drug | Tenofovir 28 week |
| Tenofovir Disoproxil FumarateAlso: TenofovirUse Tenofovir at 32week of gestation | Drug | Tenofovir 32 week |
Primary outcome
HBV DNA load in serum
Time frame: 40 weeks, from randomization to delivery
the difference in the percentage of mothers whose HBV DNA load in serum are less than 10*2 IU/ml at delivery among the groups
3 secondary outcomes
Intrauterine HBV infection rate of infants
Time frame: 12 months, from delivery to one-year birth date
Change in HBV DNA load
Time frame: 40 weeks, from randomization to delivery
Change in hepatitis B e antigen (HBeAg) titer
Time frame: 40 weeks, from randomization to delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
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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.
Tianyan Chen, MD,PHD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenofovir Disoproxil Fumarate in people with Hepatitis B, Chronic, run by First Affiliated Hospital Xi'an Jiaotong University 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Aug 2016. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinfeng Liu, MB (+86-13259927840, prettycaofurong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBV DNA load in serum (time frame: 40 weeks, from randomization to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2016.