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NCT ID: NCT01604850 Completed - Chronic Hepatitis C Clinical Trials

Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)

FUSION
Start date: June 2012
Phase: Phase 3
Study type: Interventional

This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12).

NCT ID: NCT01598831 Completed - Severe Sepsis Clinical Trials

Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy

Start date: October 29, 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.

NCT ID: NCT01597908 Completed - Melanoma Clinical Trials

Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma

COMBI-v
Start date: June 4, 2012
Phase: Phase 3
Study type: Interventional

This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.

NCT ID: NCT01592786 Completed - Autism Clinical Trials

An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Start date: June 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in a follow-up randomized withdrawal study.

NCT ID: NCT01592747 Completed - Autism Clinical Trials

Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine

Start date: September 2012
Phase: Phase 2
Study type: Interventional

The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

NCT ID: NCT01592318 Completed - Healthy Volunteer Clinical Trials

A Study of The Relative Bioavailability of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets in Healthy Volunteers

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

This randomized, open-label, crossover study will evaluate the relative bioavailability of ritonavir-boosted danoprevir fixed dose combination tablets (FDC) as compared to ad hoc combination of reference tablets of danoprevir and ritonavir in healthy volunteers. Subjects will be randomized to 1 of 6 treatment sequences to receive single oral doses of either an FDC of danoprevir and ritonavir or danoprevir and ritonavir as separate tablets. In a crossover design, subjects will participate in 3 study periods with at least a 7-day washout between periods. In Part 2, single dose administration of film-coated FDCs will be compared to reference tablets.

NCT ID: NCT01590654 Completed - Hepatitis B Clinical Trials

A Study Evaluating GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection

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

Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on days 1-3 and/or days 8-10. Follow-up visits are required periodically through day 43. Subjects with sustained reductions in HbsAg will be requested to return for additional follow-up follow-up visits at 3 and 6 months post last dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic, and safety assessments

NCT ID: NCT01590641 Completed - Hepatitis B Clinical Trials

A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B

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

Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 or days 1-3 and 8-10. Follow-up visits are also required periodically through day 43, and potential viral load follow-up visits at weeks 3 and 6 months post last dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic, and safety assessments

NCT ID: NCT01589822 Completed - Clinical trials for Gastrointestinal Diseases

The EVICEL® Gastrointestinal Study

Start date: June 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) for use as an adjunct to gastrointestinal (GI) surgery.

NCT ID: NCT01588496 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia

Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities

TESLA
Start date: April 5, 2012
Phase: Phase 2/Phase 3
Study type: Interventional

A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).