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NCT ID: NCT00504452 Terminated - HIV Infections Clinical Trials

Safety and Efficacy Study of KP-1461 to Treat ART-Experienced HIV+ Patients

Start date: July 2007
Phase: Phase 2
Study type: Interventional

The primary purpose of the study is to investigate the safety and efficacy of KP-1461 given every 12 hours for 124 days to HIV+ patients who have failed multiple antiretroviral regimens.

NCT ID: NCT00503698 Terminated - Clinical trials for Chronic Kidney Disease

The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis

OPPORTUNITY
Start date: July 2007
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Asia, Europe, North and South America and Oceania. The aim of the trial is to evaluate the effect of somatropin (human growth hormone) on survival (primary end-point; "time to death" and health related quality of life in adult patients on chronic haemodialysis.

NCT ID: NCT00496158 Terminated - Hepatitis B Clinical Trials

Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus

QUASH2
Start date: August 2007
Phase: Phase 3
Study type: Interventional

The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks, 72 weeks, and 96 weeks.

NCT ID: NCT00496002 Terminated - Hepatitis B Clinical Trials

Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus

QUASH 1
Start date: August 2007
Phase: Phase 3
Study type: Interventional

The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks and 96 weeks.

NCT ID: NCT00488059 Terminated - HIV Infections Clinical Trials

A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients

AMICI
Start date: June 2007
Phase: Phase 4
Study type: Interventional

This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study (Phase I), eligible patients received Fuzeon 90 mg subcutaneously (SC) twice daily until confirmation of response (min/max = 8/16 weeks). In Phase II, the randomised comparator phase of the study, responders were randomized to receive Fuzeon either 90 mg SC twice a day or 180 mg SC once a day for a further 16 weeks. Non-responders and virological failures were terminated from the study. The anticipated time on study treatment was 3-9 months, and the target sample size was 210 individuals.

NCT ID: NCT00449605 Terminated - Clinical trials for Diabetes Mellitus, Type 2

A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes

ALLEGRO
Start date: March 2007
Phase: Phase 3
Study type: Interventional

The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg od versus glimepiride od in reducing HbA1c in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months. The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.

NCT ID: NCT00436748 Terminated - Anemia Clinical Trials

Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease

Start date: September 16, 2008
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are the following: 1. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa once a week (QW) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis, and 2. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa every 2 weeks (Q2W) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis.

NCT ID: NCT00429702 Terminated - Nausea Clinical Trials

Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy

Start date: October 2007
Phase: Phase 2
Study type: Interventional

RATIONALE: Diphenhydramine, lorazepam, and dexamethasone may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. It is not yet known whether diphenhydramine, lorazepam, and dexamethasone are more effective than standard therapy in treating nausea and vomiting caused by chemotherapy. PURPOSE: This randomized phase II trial is studying diphenhydramine, lorazepam, and dexamethasone to see how well they work compared with standard therapy in treating nausea and vomiting caused by chemotherapy in young patients with newly diagnosed cancer.

NCT ID: NCT00406653 Terminated - Crohn's Disease Clinical Trials

A Study of Abatacept in Patients With Active Crohn's Disease

Start date: December 2006
Phase: Phase 3
Study type: Interventional

The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active Crohn's Disease in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied.

NCT ID: NCT00385567 Terminated - HIV Infections Clinical Trials

A Trial of PEHRG214 in HIV-Infected Patients

Start date: January 2007
Phase: Phase 2
Study type: Interventional

HRG2 is a Phase 2 randomized, controlled, open-label, multi-dose trial to determine the efficacy, safety, immunogenicity, and pharmacokinetic profile of PEHRG214 in HIV-infected patients, treated three times weekly for up to 16 weeks. All patients are receiving optimized standard of care HAART. The primary objective of the study is to determine the effect of PEHRG214 in decreasing the viral load (>=1.0 log10), as compared to a Control group. The primary hypothesis is that treatment with PEHRG214 will result in clinically meaningful and sustained viral load suppression. The total sample size is 70-74 patients from approximately 8-10 participating study centers. The first 16-20 patients are enrolled in the non-randomized "pilot arm" and 54 subsequent patients are randomized (2:1 within center) to Treatment or Control group. The total study duration is 7-12 months.