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NCT ID: NCT01855997 Completed - Clinical trials for Hepatitis B, Chronic

A Study to Collect Blood Biomarker Samples From Patients With Chronic Hepatitis B Who Received Treatment With Pegasys (Peginterferon Alfa-2a) +/- Nucleos(t)Ide Analogue

Start date: August 2013
Phase: N/A
Study type: Observational

This phase 4 study is designed for the collection of blood biomarker samples from patients who have completed chronic hepatitis B treatment with at least 25 weeks of a Pegasys (peginterferon alfa 2a) containing regimen and at least 24 weeks post-treatment follow-up. Patients may be enrolled from historical studies supported or sponsored by Roche, ongoing studies supported or sponsored by Roche or from general medical practice. The follow-up of patients who choose to participate in this study will be in accordance with the ongoing studies or with the general medical practice of the physician. Data from whole blood DNA samples collected in the GV28555 study or available from previously collected Roche Clinical Repository (RCR) samples will be used for combined analysis with data from other applicable studies. Procedures will include blood sample collection (not applicable for patients who previously have consented and donated RCR DNA samples) and medical record capture.

NCT ID: NCT01854918 Completed - Clinical trials for Hyperlipidemia and Mixed Dyslipidemia

Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia

OSLER-2
Start date: April 23, 2013
Phase: Phase 3
Study type: Interventional

This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

NCT ID: NCT01853826 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)

Start date: July 17, 2013
Phase: Phase 3
Study type: Interventional

To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI

NCT ID: NCT01850238 Completed - Alzheimer Disease Clinical Trials

Safety Study of AADvac1, a Tau Peptide-KLH-Conjugate Active Vaccine to Treat Alzheimer's Disease

Start date: May 2013
Phase: Phase 1
Study type: Interventional

This first-time-in-man study is mainly designed to assess the safety and tolerability of AADvac1 in the treatment of Alzheimer's disease. AADvac1 is a vaccine directed against pathologically modified Alzheimer tau protein that is the main constituent of neurofibrillary tangles (NFTs), and is intended to be a disease-modifying treatment for Alzheimer's disease, i.e. to halt its progress. As this study is a Phase I study focused on tolerability and safety, efficacy will be assessed in an exploratory manner.

NCT ID: NCT01850212 Completed - HIV Infections Clinical Trials

A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects

Start date: February 2013
Phase: Phase 4
Study type: Observational

A Phase 4 study is to characterize the profile of low bone mineral density (BMD) in ≥ 50 year old male subjects and post-menopausal female subjects on any tenofovir disoproxil fumarate (TDF)-based regimen

NCT ID: NCT01850030 Completed - Female Infertility Clinical Trials

A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization

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

Female inability to conceive a child. The purpose of this randomized, two-arm and double blind, double dummy study is to demonstrate that the treatment of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the daily dose of 3x200 mg micronized progesterone capsules administered intravaginally for the luteal support in patients undergoing IVF. The treatment will start on the day of oocyte retrieval and continue until pregnancy is negative or until week 12 gestation.Patients will be followed after treatment until 30 days after delivery to record any safety and tolerability data of the patient and their newborn(s).

NCT ID: NCT01847898 Completed - Clinical trials for Vertebral Body Fractures

Study on the Treatment of Osteoporotic Vertebral Fractures Using Vertebral Body Stenting

Start date: September 1, 2009
Phase: Phase 4
Study type: Interventional

This is a randomized, controlled study to document and evaluate the clinical performance of the Vertebral Body Stenting (VBS) System in osteoporotic fractures of the thoracic and lumbar spine. The randomized, controlled trial (RCT) will compare patients with VBS and Balloon Kyphoplasty.

NCT ID: NCT01847508 Completed - Humerus Fractures Clinical Trials

PHILOS Augmented - a Multicenter Randomized Controlled Trial

Start date: October 2013
Phase: N/A
Study type: Interventional

The primary objective is to compare the mechanical failure risks in the first year after treatment.

NCT ID: NCT01847274 Completed - Ovarian Neoplasms Clinical Trials

A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

Start date: June 21, 2013
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).

NCT ID: NCT01846832 Completed - Infection Clinical Trials

A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection

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

The purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) in previously untreated adult participants with genotype 1 or genotype 4 chronic Hepatitis C Virus (HCV) infection.