Induction of Fibrosis Regression on Patients With Chronic Hepatitis B Infection

NCT01341106 | Terminated Phase 4

• 3 other identifiers: CTC-A 11-0182010-019884-1211-018
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis B, Chronic; Liver Fibrosis

Keywords

chronic hepatitis B; liver fibrosis; treatment with Entecavir

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  12 Month

• Sensitivity and specificity of non-invasive marker at the baseline in comparison to liver biopsy as a gold standard

  12 Month

• Changes on FibroScan-measurement (LSM) and serum parameter

  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.

  6, 12, 18, 24, 32, 48 and 60 month

• Quota of patients with normalization of Alanine transaminase(ALT)-measurement in blood at separate timepoints

  6,12, 18, 24, 32, 48 and 60 month

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Patients will be treated with entecavir

Drug: Treatment with entecavir(Baraclude®)

Interventions

Treatment with entecavir(Baraclude®) DRUG

Patient will be daily treated with 1 tablet of entecavir per oral

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• weeks after surgical sterilization by bilateral tubal transection or after bilateral oophorectomy with or without hysterectomy
• 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
• Patients willing and able to complete the requirements of this study

You may not qualify if:

• anamnestic known hypersensitivity to Baraclude® or its ingredients or to drugs with similar chemical structure
• 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
• serious, chronic disease with an estimated prognosis for survival shorter than the study period of 5 years
• 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

Sponsors & Collaborators

• RWTH Aachen University: lead
• Hannover Medical School: collaborator

Study Sites (1)

Department of Internal Medicin III, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Liver Cirrhosis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Hepatitis B; 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; Fibrosis

Study Officials

• Christian Trautwein, Professor MD

  Department of Internal Medicine III, University Hospital Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 25, 2011
• Study Start: April 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

DE (1)