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NCT ID: NCT01949805 Completed - Polycythemia Vera Clinical Trials

Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera

PROUD-PV
Start date: September 2013
Phase: Phase 3
Study type: Interventional

Phase III study to compare the efficacy and safety of the novel monopegylated interferon alpha 2b AOP2014 versus Hydroxyurea (the current licensed therapy for this disease). One year treatment of patients with polycythemia vera. Objective is to demonstrate non-inferiority of AOP2014 vs. HU in terms of disease response rate in both HU naïve and currently treated patients, diagnosed with Polycythemia Vera. Response is measured as normalisation of key lab parameters as well as normalized spleen size.

NCT ID: NCT01949311 Completed - Atopic Dermatitis Clinical Trials

Open-label Study of Dupilumab in Patients With Atopic Dermatitis

Start date: October 10, 2013
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD). The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment. Optional Sub-Study: The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product. The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.

NCT ID: NCT01947946 Terminated - Asthma Clinical Trials

Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

Start date: November 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on medium doses of ICS-LABA.

NCT ID: NCT01947907 Completed - Clinical trials for Growth Hormone Deficiency (GHD)

Safety, PK/PD and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

Start date: July 2013
Phase: Phase 2
Study type: Interventional

A six month study of ACP-001, a long-acting growth hormone product, versus standard human growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone (hGH) will be given on a daily basis. The primary aim is to demonstrate safety, pharmacokinetics and pharmacodynamics over a period of six months. A secondary objective is the comparison of height velocity (HV) of the ACP-001 treated groups to the daily hGH treatment group.

NCT ID: NCT01946620 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Show That Flutiform is Well Tolerated and Effective in the Treatment of COPD

Start date: October 2013
Phase: Phase 3
Study type: Interventional

Efficacy of Fluticasone/Formoterol in COPD Treatment. The Effect study.

NCT ID: NCT01945593 Completed - Hemophilia A Clinical Trials

BAX 855 Continuation

Start date: October 15, 2013
Phase: Phase 3
Study type: Interventional

To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients (PTPs) aged ≤ 75 years of age with severe hemophilia A.

NCT ID: NCT01940471 Completed - Clinical trials for HBeAg-positive Chronic Hepatitis B

Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen

Start date: September 11, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection.

NCT ID: NCT01936181 Completed - Clinical trials for Rheumatoid Arthritis

A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Start date: August 2013
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB2 compared to Remicade in subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy.

NCT ID: NCT01933932 Active, not recruiting - Clinical trials for Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

SELECT-1
Start date: September 25, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel

NCT ID: NCT01930188 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes

SUSTAIN™ 2
Start date: December 2, 2013
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or TZD (thiazolidinedione) in subjects with type 2 diabetes.