Chronic Hepatitis BEarly Phase 1NCT04507607
Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection
A Early Phase 1 study testing Tenofovir Alafenamide 25 MG in people with Chronic Hepatitis B and Mother-to-child Block, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The effectiveness of mother-to-child block of CHB in pregnant women in the middle and later stages of pregnancy has been recognized by the guidelines. TAF, as a newly marketed antiviral drug, has not been conclusively concluded in terms of its efficacy and postpartum safety in preventing mother-to-child transmission… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Chronic Hepatitis B, Mother-to-child Block, Antiviral Treatment
- What is being tested?
- Tenofovir Alafenamide 25 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 30 Jun 2021
- Phase
- Early Phase 1
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 25 pregnant women with HBeAg (+), HBV DNA ≥ 2*10^6IU/mL who met the diagnostic criteria in the guidelines for the prevention and treatment of chronic hepatitis B were pregnant women at 24-28 weeks of pregnancy.
- 25 non-pregnant women with HBeAg (+), HBV DNA ≥ 2*10^6IU/mL who met the diagnostic criteria in the guidelines for the prevention and treatment of chronic hepatitis B.
- The enrolled patients were all newly admitted patients without treatment, and if they did not meet the standard after completing the relevant examination, they would be removed.
Who cannot join
- Coinfection with HAV, HCV, HDV, HEV or HIV;
- A history of antiviral therapy or concurrent treatment with immunoregulatory drugs, antitumor drugs, cytotoxic drugs or immunosuppressive steroids;
- Three-dimensional ultrasonography showed fetal malformation;
- The spouse is infected with HBV;
- History of decompensated liver disease (e.g., decompensated liver disease with coagulation disorders, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites and esophageal varicose bleeding), history of liver cancer or other chronic liver disease (e.g., autoimmune hepatitis) or clinical symptoms;
- History of immune diseases;
- A history of serious cardiovascular disease;
- Other reasons the researchers considered it inappropriate to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
LinChaoshuang
Guangzhou
LiXin Xiao, 18613016355, amia1995@163.com
About this study
The effectiveness of mother-to-child block of CHB in pregnant women in the middle and later stages of pregnancy has been recognized by the guidelines. TAF, as a newly marketed antiviral drug, has not been conclusively concluded in terms of its efficacy and postpartum safety in preventing mother-to-child transmission in pregnant women.Our purpose is to explore the TAF for CHB the curative effect of pregnant and postnatal security.
Read the detailed description
After diagnosis at the infection clinic of the Third Affiliated Hospital of Sun Yat-sen University, the eligible patients were enrolled into the group.Each person will sign the informed consent prior to enrollment.
- Being tested
- Tenofovir Alafenamide 25 MG
- 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 Alafenamide 25 MGDrug
TAF was administered to pregnant women with CHB during pregnancy for mother-to-child interention.Women with chronic hepatitis B who are not pregnant receive TAF for antiviral treatment.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with CHB | Experimental | Start taking TAF at 24 weeks of gestation until delivery. The liver function, viral load and antigen status were reviewed monthly and 10 ml peripheral blood was collected. Receives: Drug: Tenofovir Alafenamide 25 MG |
| women with CHB | Active comparator | Nonpregnant women taking TAF for antiviral therapy were regularly rechecked for liver function, viral load, and antigens. Receives: Drug: Tenofovir Alafenamide 25 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver indicators of intrapartum
The level of liver function (ALT、AST)、HBV DNA、HBV Serological markers (HBsAg、HBeAg、HBeAb) in pregnant women at birth.
Measured: intrapartum
Liver indicators of postpartum
The level of liver function (ALT、AST)、HBV DNA、HBV Serological markers (HBsAg、HBeAg、HBeAb) in pregnant women 1 month、3 month、7 month、9 month、12 month after delivery.
Measured: 12 months postpartum
Secondary outcomes (1)
Liver indicators of pregnancy
The level of liver function (ALT、AST)、HBV DNA、HBV Serological markers (HBsAg、HBeAg、HBeAb) in pregnant women taking TAF 0、4、8、12 weeks.
Measured: 24 weeks gestation until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Aug 2020
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaoshuang Lin, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507607
- Sponsor's protocol ID
- 0237801
- Status last verified
- Dec 2020
- First submitted
- 18 Jul 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection
- ClinicalTrials.gov ID
- NCT04507607
- Acronym / sponsor ID
- 0237801
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 11 Aug 2020 (actual)
- 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.
The effectiveness of mother-to-child block of CHB in pregnant women in the middle and later stages of pregnancy has been recognized by the guidelines. TAF, as a newly marketed antiviral drug, has not been conclusively concluded in terms of its efficacy and postpartum safety in preventing mother-to-child transmission in pregnant women.Our purpose is to explore the TAF for CHB the curative effect of pregnant and postnatal security.
Detailed description
After diagnosis at the infection clinic of the Third Affiliated Hospital of Sun Yat-sen University, the eligible patients were enrolled into the group.Each person will sign the informed consent prior to enrollment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with CHB | Experimental | Drug: Tenofovir Alafenamide 25 MGStart taking TAF at 24 weeks of gestation until delivery. The liver function, viral load and antigen status were reviewed monthly and 10 ml peripheral blood was collected. |
| women with CHB | Active comparator | Drug: Tenofovir Alafenamide 25 MGNonpregnant women taking TAF for antiviral therapy were regularly rechecked for liver function, viral load, and antigens. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 25 pregnant women with HBeAg (+), HBV DNA ≥ 2*10^6IU/mL who met the diagnostic criteria in the guidelines for the prevention and treatment of chronic hepatitis B were pregnant women at 24-28 weeks of pregnancy.
- 25 non-pregnant women with HBeAg (+), HBV DNA ≥ 2*10^6IU/mL who met the diagnostic criteria in the guidelines for the prevention and treatment of chronic hepatitis B.
- The enrolled patients were all newly admitted patients without treatment, and if they did not meet the standard after completing the relevant examination, they would be removed.
Key exclusion criteria (8 listed)
- Coinfection with HAV, HCV, HDV, HEV or HIV;
- A history of antiviral therapy or concurrent treatment with immunoregulatory drugs, antitumor drugs, cytotoxic drugs or immunosuppressive steroids;
- Three-dimensional ultrasonography showed fetal malformation;
- The spouse is infected with HBV;
- History of decompensated liver disease (e.g., decompensated liver disease with coagulation disorders, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites and esophageal varicose bleeding), history of liver cancer or other chronic liver disease (e.g., autoimmune hepatitis) or clinical symptoms;
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 Alafenamide 25 MGTAF was administered to pregnant women with CHB during pregnancy for mother-to-child interention.Women with chronic hepatitis B who are not pregnant receive TAF for antiviral treatment. | Drug | Pregnant women with CHB, women with CHB |
Primary outcome
Liver indicators of intrapartum
Time frame: intrapartum
The level of liver function (ALT、AST)、HBV DNA、HBV Serological markers (HBsAg、HBeAg、HBeAb) in pregnant women at birth.
Liver indicators of postpartum
Time frame: 12 months postpartum
The level of liver function (ALT、AST)、HBV DNA、HBV Serological markers (HBsAg、HBeAg、HBeAb) in pregnant women 1 month、3 month、7 month、9 month、12 month after delivery.
1 secondary outcome
Liver indicators of pregnancy
Time frame: 24 weeks gestation until delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
Related trials for Chronic Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tenofovir Alafenamide 25 MG in people with Chronic Hepatitis B and Mother-to-child Block, run by Third Affiliated Hospital, Sun Yat-Sen 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 3 inclusion and 8 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 22 Dec 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver indicators of intrapartum (time frame: intrapartum). The study lists 2 primary outcomes in all. 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 22 Dec 2020.