Hepatitis B, ChronicPhase 4INFIRENCT01341106
Induction of Fibrosis Regression on Patients With Chronic Hepatitis B Infection
A Phase 4 study testing Treatment with entecavir(Baraclude®) in people with Hepatitis B, Chronic and Liver Fibrosis, run by RWTH Aachen University at 1 site in Germany.
Trial summary
This study will examine whether 12 month treatment with entecavir(Baraclude®) has an effect on changes of liver stiffness measurement (LSM) and of hyaluronan measurement in patients with chronic hepatitis B infection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis B, Chronic, Liver Fibrosis
- What is being tested?
- Treatment with entecavir(Baraclude®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Apr 2015
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic hepatitis B infection with detectable HBV (hepatitis B virus)-DNA at baseline
- results of a current liver biopsy (date of liver biopsy must not be longer than 3 months as date of screening visit)
- detection of relevant liver fibrosis in liver histology after percutaneous or laparoscopic biopsy (histologically ≥ F2) after estimation by an experienced pathologist in the liver pathology and sufficient evaluability of the biopsy (usually evaluation of portal at least 8 fields)
- Therapy indication according to current guidelines cHBV infection ( any virus replication in the presence of liver cirrhosis, or detection of HBV-DNA ≥ 2000 IU / ml and/or liver histology with inflammatory Grade ≥2 / fibrosis stage 2 and presence of ALT <5 x ULN)
- non-pregnant and non-breastfeeding women, who fitful one of following criteria: * post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum FSH (follicle stimulating hormone)> 40mlU/ml)
- 6 weeks after surgical sterilization by bilateral tubal transection or after bilateral oophorectomy with or without hysterectomy
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- Correct application of two methods of sure contraception (any combination of a hormonal contraceptive (the pill, hormone IUD (intrauterine device), Depo-Provera, Implanon, contraceptive patch or vaginal ring) or IUD with a barrier contraceptive with spermicide (diaphragm, cervical cap, LEA contraceptive, female condoms or condom)or a spermicide.
- Sexual abstinence for 2 weeks before the first administration of the study medication, during the study period and after the study during 30 days (time of elimination of study medication)
- Patients, who have only female sexual partners
- Male partner of a female patient, who before study inclusion, sterile and only one sexual partner of this female patient is
- Patients willing and able to complete the requirements of this study
Who cannot join
- anamnestic known hypersensitivity to Baraclude® or its ingredients or to drugs with similar chemical structure
- Participation of patients in another clinical study within last 4 weeks prior to the inclusion or simultaneous participation in another clinical study
- anamnestic known substance dependance or another diseases, which not allowed persons to understand essence and importance and possible consequences of the trial
- lack of cooperation and informed consent
- co-infection with hepatitis C, hepatitis D or HIV
- detection of hepatocellular carcinoma
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- serious, chronic disease with an estimated prognosis for survival shorter than the study period of 5 years
- every previous therapy with lamivudine or telbivudine or previous therapy with other antiviral substance within last 6 months before study inclusion
- contraindications to the use of entecavir
- creatinine clearance <50 ml / min and / or need for hemodialysis
- MELD score >15 points and / or detection of ascites
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal Medicin III, University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
This study will examine whether 12 month treatment with entecavir(Baraclude®) has an effect on changes of liver stiffness measurement (LSM) and of hyaluronan measurement in patients with chronic hepatitis B infection.
Read the detailed description
Patients with chronic hepatitis B infection and relevant liver fibrosis will be treated with entecavir during 5 years or until anti-HBs seroconversion or 6-12 months after anti-HBe seroconversion and HBeAg loss. There are 9 visits during treatment for each patient. At all visits, each patient will consent to give 20 ml blood sample for study examination and 40 ml blood sample for research purposes.
- Conditions
- Hepatitis B, Chronic, Liver Fibrosis
- Being tested
- Treatment with entecavir(Baraclude®)
- Keywords
- chronic hepatitis B, liver fibrosis, treatment with Entecavir
- Medical subject headings
- Hepatitis B, Chronic, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with entecavir(Baraclude®)Drug
Patient will be daily treated with 1 tablet of entecavir per oral
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Patients will be treated with entecavir Receives: Drug: Treatment with entecavir(Baraclude®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of liver stiffness measurement (LSM) and hyaluronan measurement in blood
Changes of liver stiffness measurement (LSM) and hyaluronan measurement in blood will be checked as markers of fibrous tissue in the liver after treatment with entecavir(Baraclude®) within 12 month.
Measured: 12 Month
Secondary outcomes (7)
Changes on Pro-Collagen-III-N-Peptid, Tissue Inhibitor of Metalloproteinases (TIMP-1) and Chitinase-3-like protein 1(YKL-40) in serum
Changes on Pro-Collagen-III-N-Peptid, Tissue Inhibitor of Metalloproteinases (TIMP-1) and Chitinase-3-like protein 1(YKL-40) in serum will be checked after 12 month treatment.
Measured: 12 Month
Sensitivity and specificity of non-invasive marker at the baseline in comparison to liver biopsy as a gold standard
Non-invasive marker(liver stiffness measurement(LSM) with FibroScan and serum parameter(hyaluronan measurement, Pro-Collagen-III-N-Peptid, Tissue Inhibitor of Metalloproteinases(TIMP-1) and Chitinase-3-like protein 1(YKL-40))) at the baseline will be compared with results of liver biopsy as gold standard after treatment with entecavir(Baraclude®) within 12 month.
Measured: 12 Month
Changes on FibroScan-measurement (LSM) and serum parameter
Changes on FibroScan-measurement (LSM) and serum parameter (hyaluronan measurement, Pro-Collagen-III-N-Peptid, Tissue Inhibitor of Metalloproteinases(TIMP-1) and Chitinase-3-like protein 1(YKL-40))) will be checked at timepoints of 6,12,18,24,36,48 and 60 month after treatment with entecavir(Baraclude®) within 12 month.
Measured: 6,12,18,24,36,48 and 60 month
Decrease of hepatitis B virus-DNA and quota of patients with non-detectable hepatitis B virus-DNA at separate timepoints.
Measurement of decrease of hepatitis B virus-DNA and quota of patients with non-detectable hepatitis B virus-DNA at several timepoints after treatment with entecavir(Baraclude®) within 12 month.
Measured: 6, 12, 18, 24, 32, 48 and 60 month
Quota of patients with normalization of Alanine transaminase(ALT)-measurement in blood at separate timepoints
Quota of patients with normalization of Alanine transaminase(ALT)-measurement in blood will be checked at separate timepoints after treatment with entecavir(Baraclude®) within 12 month.
Measured: 6,12, 18, 24, 32, 48 and 60 month
Quota of patients with hepatitis B viral protein loss, antibodies to the the hepatitis B 'e' antigen seroconversion, surface antigen of the Hepatitis-B-Virus loss and antibodies to the hepatitis B core antigen seroconversion at separate timepoints
Quota of patients with core antigen hepatitis B viral protein (HBeAg) loss, antibodies to the the hepatitis B 'e' antigen(anti-HBe) seroconversion, surface antigen of the Hepatitis-B-Virus(HBsAg) loss and antibodies to the hepatitis B core antigen(anti-HBs) seroconversion will be checked at separate timepoints after treatment with entecavir(Baraclude®) within 12 month.
Measured: 6,12, 18, 24, 32, 48 and 60 month
Incidence of side effects
Incidence of appearance of side effects of after 12 month treatment with entecavir(Baraclude®)within whole study period of 60 month.
Measured: 60 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2015
- Study completionApr 2015
Why it stopped: insufficient patient numbers have been recruited
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.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School
- Responsible party
- Sponsor
- Investigators
- Christian Trautwein, Professor MD, Principal investigator, Department of Internal Medicine III, University Hospital Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341106
- Sponsor's protocol ID
- CTC-A 11-018
- Other IDs
- 2010-019884-12, 11-018
- Acronym
- INFIRE
- Status last verified
- Sep 2015
- First submitted
- 20 Apr 2011
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Fibrosis Regression on Patients With Chronic Hepatitis B Infection
- ClinicalTrials.gov ID
- NCT01341106
- Acronym / sponsor ID
- INFIRE / CTC-A 11-018
- Conditions
- Hepatitis B, Chronic, Liver Fibrosis
- Keywords
- chronic hepatitis B, liver fibrosis, treatment with Entecavir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient patient numbers have been recruited
- Enrolment
- 7 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Hannover Medical School
- Study start
- Apr 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 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.
This study will examine whether 12 month treatment with entecavir(Baraclude®) has an effect on changes of liver stiffness measurement (LSM) and of hyaluronan measurement in patients with chronic hepatitis B infection.
Detailed description
Patients with chronic hepatitis B infection and relevant liver fibrosis will be treated with entecavir during 5 years or until anti-HBs seroconversion or 6-12 months after anti-HBe seroconversion and HBeAg loss. There are 9 visits during treatment for each patient. At all visits, each patient will consent to give 20 ml blood sample for study examination and 40 ml blood sample for research purposes.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Treatment with entecavir(Baraclude®)Patients will be treated with entecavir |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- chronic hepatitis B infection with detectable HBV (hepatitis B virus)-DNA at baseline
- results of a current liver biopsy (date of liver biopsy must not be longer than 3 months as date of screening visit)
- detection of relevant liver fibrosis in liver histology after percutaneous or laparoscopic biopsy (histologically ≥ F2) after estimation by an experienced pathologist in the liver pathology and sufficient evaluability of the biopsy (usually evaluation of portal at least 8 fields)
- Therapy indication according to current guidelines cHBV infection ( any virus replication in the presence of liver cirrhosis, or detection of HBV-DNA ≥ 2000 IU / ml and/or liver histology with inflammatory Grade ≥2 / fibrosis stage 2 and presence of ALT <5 x ULN)
- non-pregnant and non-breastfeeding women, who fitful one of following criteria: * post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum FSH (follicle stimulating hormone)> 40mlU/ml)
Key exclusion criteria (11 listed)
- anamnestic known hypersensitivity to Baraclude® or its ingredients or to drugs with similar chemical structure
- Participation of patients in another clinical study within last 4 weeks prior to the inclusion or simultaneous participation in another clinical study
- anamnestic known substance dependance or another diseases, which not allowed persons to understand essence and importance and possible consequences of the trial
- lack of cooperation and informed consent
- co-infection with hepatitis C, hepatitis D or HIV
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 |
|---|---|---|
| Treatment with entecavir(Baraclude®)Patient will be daily treated with 1 tablet of entecavir per oral | Drug | Treatment Arm |
Primary outcome
Changes of liver stiffness measurement (LSM) and hyaluronan measurement in blood
Time frame: 12 Month
Changes of liver stiffness measurement (LSM) and hyaluronan measurement in blood will be checked as markers of fibrous tissue in the liver after treatment with entecavir(Baraclude®) within 12 month.
7 secondary outcomes
Changes on Pro-Collagen-III-N-Peptid, Tissue Inhibitor of Metalloproteinases (TIMP-1) and Chitinase-3-like protein 1(YKL-40) in serum
Time frame: 12 Month
Sensitivity and specificity of non-invasive marker at the baseline in comparison to liver biopsy as a gold standard
Time frame: 12 Month
Changes on FibroScan-measurement (LSM) and serum parameter
Time frame: 6,12,18,24,36,48 and 60 month
Decrease of hepatitis B virus-DNA and quota of patients with non-detectable hepatitis B virus-DNA at separate timepoints.
Time frame: 6, 12, 18, 24, 32, 48 and 60 month
Quota of patients with normalization of Alanine transaminase(ALT)-measurement in blood at separate timepoints
Time frame: 6,12, 18, 24, 32, 48 and 60 month
Quota of patients with hepatitis B viral protein loss, antibodies to the the hepatitis B 'e' antigen seroconversion, surface antigen of the Hepatitis-B-Virus loss and antibodies to the hepatitis B core antigen seroconversion at separate timepoints
Time frame: 6,12, 18, 24, 32, 48 and 60 month
Incidence of side effects
Time frame: 60 month
Results and safety
The study was stopped early (reason given: insufficient patient numbers have been recruited). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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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.
Christian Trautwein, Professor MD principal investigator
Department of Internal Medicine III, University Hospital Aachen
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 Treatment with entecavir(Baraclude®) in people with Hepatitis B, Chronic and Liver Fibrosis, run by RWTH Aachen University at 1 site in Germany.
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 11 inclusion and 11 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: stopped early, as of the sponsor's last update on 23 Sep 2015. 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 Germany. 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 was stopped early (reason given: insufficient patient numbers have been recruited). Results are not available in the source record.
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?
Changes of liver stiffness measurement (LSM) and hyaluronan measurement in blood (time frame: 12 Month). 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 23 Sep 2015.