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NCT ID: NCT01265511 Completed - Clinical trials for Hepatitis C Infection

Study of SCY-635, Pegasys and Copegus in Hepatitis C

Start date: November 2010
Phase: Phase 2
Study type: Interventional

This study will examine the effectiveness of 28 days of triple combination therapy including SCY-635 with peginterferon alfa 2a and ribavirin in reducing serum HCV RNA levels. An additional 20 weeks of treatment with the currently approved standard of care will be offered to all participants. The Week 24 visit will be the last on-study visit. After the Week 24 visit, all subjects with undetectable HCV RNA will be given the option to continue treatment with standard of care for an additional 24 weeks (out to Week 48) under the care of their Principal Investigator.

NCT ID: NCT01262677 Completed - Epilepsies, Partial Clinical Trials

Once-A-Day Pregabalin For Partial Seizures

Start date: February 17, 2011
Phase: Phase 3
Study type: Interventional

Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.

NCT ID: NCT01262651 Completed - Pain Clinical Trials

Sativex® for Relieving Persistent Pain in Participants With Advanced Cancer

Start date: November 25, 2010
Phase: Phase 3
Study type: Interventional

This 9-week study aimed to determine the efficacy, safety and tolerability of nabiximols (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in participants with advanced cancer. Eligible participants were not required to stop any of their current treatments or medications.

NCT ID: NCT01262365 Completed - Clinical trials for Systemic Lupus Erythematosus

Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus

EMBODY1
Start date: December 2010
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)

NCT ID: NCT01261325 Completed - Epilepsy Clinical Trials

Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures

BRITE
Start date: December 2010
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs.

NCT ID: NCT01258608 Completed - Clinical trials for Carcinoma, Hepatocellular

Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma

Start date: February 8, 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Mapatumumab is a fully human, agonist monoclonal antibody that activates the cell death pathway in tumor cells by specifically binding to TRAIL-R1 with high affinity. Sorafenib, a multikinase inhibitor, is the standard of care for treatment of patients with advanced hepatocellular carcinoma (HCC). The mechanisms of sorafenib and mapatumumab action suggest that these agents could interact synergistically. This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of mapatumumab in combination with sorafenib in subjects with advanced hepatocellular carcinoma.

NCT ID: NCT01254175 Completed - Clinical trials for Parainfluenza Virus 3, Human

Evaluating the Safety and Immunogenicity of a Human Parainfluenza Type 3 (HPIV3) Virus Vaccine in Infants and Children

Start date: December 2010
Phase: Phase 1
Study type: Interventional

Human parainfluenza virus type 3 (HPIV3) is a major cause of pneumonia and other respiratory diseases in infants and children. This study will evaluate the safety and immune response of an HPIV3 vaccine in infants and young children.

NCT ID: NCT01252940 Completed - HIV-1 Infection Clinical Trials

Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment option to patients who wish to simplify dosing by reducing pill burden or to improve the tolerability of their treatment. Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which participants will switch treatment regimens at the start of the study, and the Stay on Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their baseline regimen during the first 24 weeks of the study (designed to provide an initial active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit. After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF STR per protocol before switching to a commercially available source.

NCT ID: NCT01250366 Completed - HCV (Genotype 1) Clinical Trials

Study of the Safety & PK of INX-08189 in Chronically-infected HCV, Treatment-naïve Subjects

Start date: October 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the Safety and Pharmacokinetics of Multiple Ascending Oral Doses of INX-08189 in Chronically-infected Genotype 1 HCV, Treatment-naïve Subjects.

NCT ID: NCT01244763 Completed - Anemia Clinical Trials

Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia

Start date: October 29, 2010
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease.