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Hepatitis, Chronic clinical trials

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NCT ID: NCT02339207 Completed - Chronic Hepatitis C Clinical Trials

First in Human Study of AL-335; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1

Start date: December 31, 2014
Phase: Phase 1
Study type: Interventional

This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered AL-335 in healthy volunteers (HV) and subjects with CHC infection.

NCT ID: NCT02339038 Completed - HCV HIV Clinical Trials

Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia

Start date: January 7, 2015
Phase: Phase 4
Study type: Interventional

Background: - Treatment for Hepatitis C has changed a lot in the past 2 years. Most of this change comes from a combination of medicines that is yielding high cure rates. But its long-term effects are uncertain. One problem is that a lot of people need the treatment, but only a few specialists can give it. The success rate for Hepatitis C treatment by primary care doctors, nurse practitioners, or physician assistants is largely unknown. Researchers want to see how provider type affects treatment outcomes. They will conduct a large, community-based study in the District of Columbia. Objectives: - To see if people can be treated for Hepatitis C safely and successfully in community-based health centers. Eligibility: - Adults who need treatment for chronic Hepatitis C infection. Design: - Participants will be screened with blood tests. Their current medicines will be reviewed. - Participants will give researchers access to their medical records. Researchers will follow participants through these records. - Participants will see a primary care or infectious disease provider. The provider will tell them about their treatment. They will be told how often they will visit the provider and how often they will have their blood drawn. They will get a calendar of study visits. - Participants will take Harvoni for 8, 12, or 24 weeks. They will visit their care provider monthly. - Participants will have monthly follow-up visits for up to 3 months after they finish their medicine. - Participants will have yearly follow-up visits with their care provider for up to 10 years.

NCT ID: NCT02337127 Recruiting - Chronic Hepatitis B Clinical Trials

Lamivudine Extending Therapy in Chronic Hepatitis B Patients After 3-year of Oral Antiviral Agents

Start date: June 2011
Phase: Phase 4
Study type: Interventional

Current treatment guidelines indicate that oral antiviral agents for HBeAg-positive chronic hepatitis B virus infection (CHB) can be stopped if the patient has undergone HBeAg seroconversion with HBV-DNA loss measured at two consecutive occasions at least 6 months apart (primary treatment endpoint). Stopping treatment can be considered if undetectable HBV-DNA has been documented on three separate occasions 6 months apart in HBeAg-negative patients. However, oral antiviral drugs currently approved for the treatment of CHB have relatively limited sustained long-term efficacy and a large proportion of patients will suffer from HBV recurrence after stopping treatment.

NCT ID: NCT02336399 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Sustained HBsAg and Viral Response in Patients Achieved HBsAg Loss by Interferon Treatment

Start date: September 2008
Phase: N/A
Study type: Observational

Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of cirrhosis and hepatocellular carcinoma (HCC).HBsAg loss/seroconversion is considered to be the ideal endpoint of antiviral therapy in both HBeAg-positive and HBeAg-negative patients, as well as the ultimate treatment goal in CHB. However, some patients who have achieved HBsAg loss would reverse back to HBsAg positive, or even become HBV reactive with recurrence of viremia. In current study, the viral and HBsAg response in patients who have achieved HBsAg loss by interferon (IFN) treatment will be observed for 96 weeks after the completion of IFN treatment. The primary analysis will be performed at the end of 96 weeks. Following the completion of the study period of 96 weeks, patients will be offered to participate in a long term study for further observation of additional 144 weeks (total of 240 weeks from the enrollment).

NCT ID: NCT02336139 Completed - Hepatitis C Clinical Trials

A Phase II Trial of Sofosbuvir (SOF) and GS-5816 for People With Chronic Hepatitis C Virus Infection and Recent Injection Drug Use

SIMPLIFY
Start date: March 16, 2016
Phase: Phase 2
Study type: Interventional

To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following sofosbuvir/GS-5816 therapy for 12 weeks in people with chronic HCV infection and recent injection drug use.

NCT ID: NCT02332473 Completed - Chronic Hepatitis B Clinical Trials

A Prospective Study of Combination of Peginterferon Alfa-2b (40kD, Y-shape) and GM-CSF in Chronic Hepatitis B

Start date: June 2014
Phase: Phase 2
Study type: Interventional

This study is a multi-center, randomized, prospective open-label study to assess the efficacy and safety of combination of peginterferon alfa-2b (40kD, Y-shape) and GM-CSF in interferon-naïve chronic hepatitis B patients with HBeAg positive. Patients were randomized to one of the 2 groups to receive different antiviral treatment.

NCT ID: NCT02327702 Not yet recruiting - Pregnancy Clinical Trials

Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients

Start date: January 2015
Phase: Phase 4
Study type: Interventional

This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant chronic hepatitis B patients. Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery.

NCT ID: NCT02327676 Not yet recruiting - Clinical trials for Hepatitis B, Chronic

Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients

Start date: January 2015
Phase: Phase 4
Study type: Interventional

This study evaluates generic emtricitabine(FTC) in Chinese naive children chronic hepatitis B patients. Single group of child patients were enrolled, which include HBeAg positive and negative Chronic hepatitis B(CHB)group.

NCT ID: NCT02327663 Not yet recruiting - Clinical trials for Hepatitis B, Chronic

Emtricitabine for Naive Chinese Chronic Hepatitis B Patients

Start date: December 2014
Phase: Phase 4
Study type: Interventional

This study evaluates generic emtricitabine(FTC) in Chinese naive chronic hepatitis B patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group and HBeAg negative Chronic hepatitis B(CHB)group.

NCT ID: NCT02327416 Recruiting - Clinical trials for Hepatitis B, Chronic

A Prospective Clinical Trial in Chronic Hepatitis B Patients NAs (Nucleotides or Nucleosides) Experienced (Anchor Study)

Start date: October 2014
Phase: Phase 3
Study type: Interventional

This study is a multi-center, randomized, prospective, open-label Phase III Clinical trial to assess the efficacy and safety of combination and sequential treatment with Y peginterferon Alfa-2b,entecavir and GMCSF in chronic hepatitis B patients nucleotides or nucleosides experienced. Patients were randomized to one of 3 groups to receive different antiviral treatment.