Clinical Trials Logo

Filter by:
NCT ID: NCT00196742 Recruiting - Fabry Disease Clinical Trials

Fabry Disease Registry & Pregnancy Sub-registry

Start date: July 31, 2001
Phase:
Study type: Observational [Patient Registry]

The Fabry Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician. The primary objectives of the Registry are: - To enhance the understanding of the variability, progression, and natural history of Fabry disease, including heterozygous females with the disease; - To assist the Fabry medical community with the development of recommendations for monitoring patients and reports on patient outcomes to help optimize patient care; - To characterize and describe the Fabry population as a whole; - To evaluate the long-term safety and effectiveness of Fabrazyme® Fabry Pregnancy Sub-registry: This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Fabry Registry, regardless of whether she is receiving disease-specific therapy (such as enzyme replacement therapy with agalsidase beta) and irrespective of the commercial product with which she may be treated. Data from the Sub-registry are also used to fulfill various global regulatory requirements, to support product development/reimbursement, and for other research and non-research-related purposes. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.

NCT ID: NCT00192647 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Induction Dosing With Peginterferon Alfa-2a (40KD) and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1

Start date: September 2004
Phase: Phase 4
Study type: Interventional

This study will evaluate the addition of a higher-dose induction treatment period with peginterferon alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with Pegasys and ribavirin, compared to standard-dose treatment without induction dosing, in treatment-naive participants with CHC, genotype 1. The anticipated time on study treatment is 48 weeks, and the target sample size is 500 or more individuals.

NCT ID: NCT00192595 Completed - HIV Infection Clinical Trials

Tenofovir in HIV/HBV Coinfection

TICO
Start date: January 2004
Phase: Phase 4
Study type: Interventional

The purpose of the study is to compare the effectiveness of 3 different treatment regimens in reducing or clearing the Hepatitis B Virus in patients infected with HIV and Hepatitis B (co-infection)

NCT ID: NCT00192374 Completed - Healthy Clinical Trials

Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, (CAIV-T) in Healthy Children

Start date: February 2002
Phase: Phase 3
Study type: Interventional

- Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of(CAIV-T) in Healthy Children.

NCT ID: NCT00191100 Completed - Cancer of Cervix Clinical Trials

Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix

Start date: May 2002
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of two methods of treating cancer of the cervix. Half the patients will receive gemcitabine plus cisplatin while undergoing radiation therapy, followed by adjuvant gemcitabine and cisplatin and the other half will receive cisplatin along with radiation therapy without adjuvant therapy.

NCT ID: NCT00174785 Completed - Atrial Fibrillation Clinical Trials

A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation

ATHENA
Start date: June 2005
Phase: Phase 3
Study type: Interventional

To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL). To assess that dronedarone is well tolerated in this population.

NCT ID: NCT00172042 Completed - Clinical trials for Non-Small-Cell Lung Cancer

A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC)

Start date: March 2005
Phase: Phase 3
Study type: Interventional

30-40% of patients with lung cancer will develop bone metastases during the course of their disease, which can lead to pain, decreased mobility and skeletal complications. This study will investigate the effect of zoledronic acid on preventing or delaying the development of bone metastases and the impact on disease progression/survival in patients with stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC).

NCT ID: NCT00171821 Completed - Clinical trials for Transfusion-dependent Iron Overload

A Study Assessing the Efficacy and Safety of Deferasirox in Patients With Transfusion-dependent Iron Overload

Start date: April 2005
Phase: Phase 3
Study type: Interventional

This study uses a single arm, multi-center, open-label trial design. The study will assess the efficacy and safety of 52 weeks of treatment with deferasirox (ICL670) in patients with evidence of transfusion induced iron overload.

NCT ID: NCT00171340 Completed - Breast Cancer Clinical Trials

Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.

Start date: May 2003
Phase: Phase 3
Study type: Interventional

Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.

NCT ID: NCT00169455 Completed - Clinical trials for Rotavirus Gastroenteritis

Assess the Immunogenicity of the Human Rotavirus (HRV) Vaccine After Reconstitution Without Buffering Agent; & Evaluate the Immunogenicity, Reactogenicity & Safety of the Vaccine After Storage for 7 d at 37°C Following 2 Doses in Healthy Infants

Start date: March 2005
Phase: Phase 3
Study type: Interventional

Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age. GSK Biologicals has developed a vaccine against human rotavirus gastroenteritis. In this study, the immunogenicity, reactogenicity and safety of the HRV vaccine will be evaluated when stored or reconstituted in circumstances different from the recommendations: i.e. when not reconstituted with a buffer or when stored for 7 days at 37°C before reconstitution. In addition, the effect of feeding will be explored for HRV vaccine reconstituted without buffer.