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Hepatitis B, Chronic clinical trials

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NCT ID: NCT01708889 Completed - Clinical trials for Chronic Hepatitis C Virus Infection

Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal Dysfunction

PK
Start date: September 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the effect of renal impairment on pharmacokinetics (PK) of BMS-914143.

NCT ID: NCT01706575 Completed - Clinical trials for Hepatitis B, Chronic

A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Patients With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable HBV DNA Suppression

Start date: April 2013
Phase: Phase 2
Study type: Interventional

This open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in patients with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA suppression. After a 12-week Lead-in period on treatment with NA, patients with a HBsAg decline <0.5 log10 IU/ml will enter the Add-on period to receive Pegasys 180 mcg subcutaneously weekly for 48 weeks in addition to their current NA treatment. Follow-up will be a further 48 weeks, during which the patients will continue their NA treatment.

NCT ID: NCT01705704 Completed - Clinical trials for Hepatitis B, Chronic

A Retrospective Biomarker Study of Stored Samples Obtained From Patients With Chronic Hepatitis B

Start date: June 2012
Phase: N/A
Study type: Observational

This retrospective study will evaluate the association of biomarkers and the treatment response of patients with chronic hepatitis B, who have completed therapy with Pegasys (peginterferon alfa-2a) ± lamivudine. For the analysis stored serum samples obtained from patients will be used; no actual patients are involved.

NCT ID: NCT01697501 Completed - Clinical trials for Hepatitis B, Chronic

A Study Evaluating IL28B Polymorphism in Patients With HBeAg-Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML18253

Start date: November 2012
Phase: Phase 3
Study type: Interventional

This cross-sectional multicenter study will evaluate the IL28B polymorphism in patients with HBeAg-negative chronic hepatitis B treated with Pegasys (peginterferon alfa-2a) in the predecessor ML18253 study. The study consists of a single visit where eligible patients will undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit.

NCT ID: NCT01679769 Completed - Chronic Hepatitis B Clinical Trials

Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis B

Start date: May 2012
Phase: N/A
Study type: Observational [Patient Registry]

The aim of our study is to evaluate liver fibrosis using biochemical markers, FibroScan, and radiology methods in patients with chronic hepatitis B in mainland China.

NCT ID: NCT01671787 Completed - Chronic Hepatitis B Clinical Trials

A Phase 1b Study Assessing GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B

Start date: March 2012
Phase: Phase 1
Study type: Interventional

This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil fumarate (TDF).

NCT ID: NCT01667432 Completed - Clinical trials for Hepatitis B, Chronic

An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B

Start date: July 2011
Phase: N/A
Study type: Observational

This prospective, multicenter, observational study will evaluate on-treatment predictors of response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving treatment with peginterferon alfa-2a (PEGASYS®) in accordance with local labeling and the summary of product characteristics. Data will be collected from patients for the duration of their treatment and for up to 24 weeks thereafter.

NCT ID: NCT01645969 Completed - Clinical trials for Hepatitis B, Chronic

A Follow-Up Study of Patients With HBeAg Positive Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML22265

Start date: April 2011
Phase: N/A
Study type: Observational

This multicenter, prospective, observational study will evaluate the one-year outcomes in HBeAg positive chronic hepatitis B patients who had received Pegasys (peginterferon alfa-2a) in Arm A of study ML22265. Data will be collected from each patient for up to one year post-therapy.

NCT ID: NCT01641536 Completed - Clinical trials for Hepatitis B, Chronic

Tolerability, Immunogenicity and Efficacy of HB-110 Administered by Electroporation in Chronic Hepatitis B Patients

Start date: November 2011
Phase: Phase 1
Study type: Interventional

This study is an open label, dose escalation study using the classical 3+3 design to determine the MTD of HB-110 and assess the safety, immunogenicity and efficacy of HB-110 DNA therapeutic vaccine administered by Electroporation in combination with Entecavir in chronic hepatitis B patients.

NCT ID: NCT01639092 Completed - Clinical trials for Chronic Viral Hepatitis B Without Delta-agent

Tenofovir vs. Tenofovir Plus Entecavir in Entecavir-Resistant Chronic Hepatitis B

IN-US-0202
Start date: September 28, 2012
Phase: Phase 4
Study type: Interventional

With the availability of potent nucloes(t)ide analogues (NA), such as tenofovir disoproxil fumarate (TDF) and entecavir (ETV), suppression of serum HBV DNA to undetectable levels by polymerase chain reaction (PCR) assays became achievable in most NA treatment-naïve patients. Until recently, however, many patients commenced antiviral treatment with inferior NAs prior to the availability of TDF or ETV, such as lamivudine (LAM) which has a low genetic barrier to resistance. ETV resistance increase up to 51% of patients after 5 years of ETV treatment in lamivudine-refractory patients. Resistance to ETV appears to occur through a two-hit mechanism with initial selection of M204V/I mutation followed by amino acid substitutions at rtT184, rtS202, or rtM250. In vitro studies showed that ETV-resistant mutations are susceptible to TDF, but there are little clinical data on the efficacy of TDF monotherapy in patients with ETV-resistance. On the other hand, there was a retrospective cohort study reporting that, with the combination of TDF and ETV, most of patients became HBV DNA undetectable after median 6 months of treatment. Probability of reaching complete HBV DNA suppression was not decreased in patients with ADV or ETV-resistance. Thus, there is no consistent treatment recommendation for patients with ETV-resistance. In this clinical trial, the investigators will clarify whether tenofovir monotherapy is as effective as tenofovir plus entecavir in inducing complete virologic response in CHB patients with genotypic resistance to ETV and partial virologic response to ongoing treatment.