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NCT ID: NCT01410890 Completed - Pompe Disease Clinical Trials

Pharmacokinetics of Alglucosidase Alfa in Patients With Pompe Disease

PAPAYA
Start date: November 3, 2014
Phase: Phase 4
Study type: Interventional

- The primary objective of this study was to characterize the pharmacokinetics (PK) of alglucosidase alfa manufactured at the 4000 L scale in participants who had a confirmed diagnosis of Pompe disease. - A secondary objective of this study was to evaluate and explore the relationship between anti-recombinant human acid alpha-glucosidase antibody titers and the PK of alglucosidase alfa.

NCT ID: NCT01410227 Completed - Clinical trials for Von Willebrand Disease

Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD)

Start date: November 1, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this Phase 3 study is to assess the pharmacokinetics of rVWF:rFVIII and rVWF, and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding events in subjects with severe hereditary von Willebrand disease (VWD).

NCT ID: NCT01408576 Completed - Clinical trials for Systemic Lupus Erythematosus

Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus

EMBODY4
Start date: July 2011
Phase: Phase 3
Study type: Interventional

The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

NCT ID: NCT01404585 Completed - Clinical trials for Rheumatoid Arthritis

Proof-of-Concept Study With BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis

RA
Start date: September 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess whether BMS-817399 in combination with Methotrexate is effective in treating moderate to severe rheumatoid arthritis.

NCT ID: NCT01403376 Completed - Multiple Sclerosis Clinical Trials

Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide

TERIVA
Start date: September 2011
Phase: Phase 2
Study type: Interventional

Primary Objective: Assess the antibody response to influenza vaccine in patients with relapsing form of multiple sclerosis (RMS) treated with teriflunomide compared to a reference population. Secondary Objectives: - Assess the effect of teriflunomide on immunoglobulin levels; - Assess the safety of influenza vaccination in patients with RMS treated with teriflunomide. The reference population was defined as multiple sclerosis (MS) patients with a stable treatment with interferon-β-1. Antibody response was measured using hemagglutination inhibition assay (HIA) and the hemagglutinin antigens representing the stains of H3N2, H1N1, and B as present in the influenza vaccine used.

NCT ID: NCT01402986 Completed - Asthma Clinical Trials

A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Asthma

Start date: August 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the addition of tralokinumab to standard asthma medication is effective in the treatment of adults with asthma

NCT ID: NCT01401478 Completed - Clinical trials for Secondary Hyperparathyroidism

Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation

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

Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Planned therapy will be six months. Participants with Stage 5 Chronic Kidney Disease and with hyperparathyroidism on hemodialysis will be included into the study. Ability of Zemplar, (paricalcitol) to lower intact Parathyroid Hormone level will be assessed during the study.

NCT ID: NCT01400971 Completed - Clinical trials for Diabetes Mellitus, Type 2

An Observational Study to Understand Challenges Associated With Progression of Insulin Therapy in Type 2 Diabetes

MOSAIc
Start date: July 2011
Phase:
Study type: Observational

The purpose of this study is to identify specific patient, physician, and health system related factors associated with the progression to a more intensive regimen from initial insulin therapy for patients with type 2 diabetes.

NCT ID: NCT01397786 Completed - Schizophrenia Clinical Trials

Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia

ZENITH
Start date: September 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as monotherapy in adults with schizophrenia.

NCT ID: NCT01396447 Completed - Depression, Bipolar Clinical Trials

Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

Start date: July 26, 2011
Phase: Phase 2
Study type: Interventional

The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.