Clinical trials: Planning
Polycythemia Vera
MAP to Provide Access to Ruxolitinib, for Patients With Polycythemia Vera
The purpose of this Cohort Treatment Plan is to allow access to ruxolitinib for eligible patients diagnosed with Polycythemia Vera.
- Trial name
- NCT05269771
- Testing
- Ruxolitinib
- Where
- 25 sites in Australia, Belgium and 6 more
- Sponsor
- Novartis Pharmaceuticals
Epilepsies, Partial
Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
This investigation aims to understand the following issues in pediatric patients, as well as to assess the need of a special investigation and a post-marketing clinical study: The frequency of treatment related adverse events.
- Trial name
- NCT01441401
- Testing
- gabapentin
- Volunteers
- 82 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Tuberculosis, Non-tuberculous Mycobacterial Diseases (Including MAC Disease)
Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Trial name
- NCT00810407
- Testing
- rifabutin
- Volunteers
- 628 people
- Sponsor
- Pfizer
Alzheimer's Disease
A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients
The purpose of the study is for investigation and collection of Aricept safety information with a dose increase on Alzheimer's disease patients.
- Trial name
- AID (NCT02158910)
- Testing
- Aricept
- Where
- 13 sites in South Korea
- Volunteers
- 2,231 people
- Sponsor
- Eisai Korea Inc.
Legionnaires' Disease, Legionella Pneumophila Infections
Special Investigation Of Azithromycin IV For Legionnaires' Disease (Regulatory Post Marketing Commitment Plan)
To collect retrospectively the efficacy and safety information of azithromycin IV on patients with Legionnaires' disease related to their appropriate use in daily practice.
- Trial name
- RESCUE-L (NCT01784770)
- Testing
- Azithromycin IV
- Volunteers
- 21 people
- Sponsor
- Pfizer
Helminthiasis, Amoebiasis
Study to Evaluate Efficacy and Safety of a Double Treatment Plan Using a Combination of Mebendazole and Quinfamide for Treating Intestinal Helminthiasis and Amebiasis in the Mexican Population
The purpose of this study is to assess the efficacy and safety of the combination of mebendazole plus quinfamide for the treatment of intestinal helminthiasis and amoebiasis in Mexican population.
- Trial name
- NCT02385058
- Testing
- Mebendazole, Quinfamide
- Where
- Mexico
- Volunteers
- 100 people
- Sponsor
- Janssen-Cilag Ltd.
Bacterial Infections
Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)
To collect the efficacy and safety information of Zithromax-SR related to their appropriate use in daily practice.
- Trial name
- NCT00998309
- Testing
- Azithromycin SR
- Volunteers
- 502 people
- Sponsor
- Pfizer
Transthyretin Familial Amyloid Polyneuropathy
Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
The purpose of this study is to understand safety (e.g., occurrence of adverse drug reactions [ADRs]) and efficacy data on the long-term use of Vyndaqel Capsules (hereinafter referred to as Vyndaqel) in all patients who received…
- Trial name
- NCT02146378
- Testing
- Vyndaqel
- Volunteers
- 500 people
- Sponsor
- Pfizer
Hematopoietic Stem Cell Transplant Associated Thrombotic Microangiopathy (HSCT-TMA)
Single Patient Expanded Access Treatment Plan For The Investigational Product Narsoplimab
The purpose of the EAP is to provide access to hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) patients who may benefit from treatment with narsoplimab based on the medical judgement of their…
- Trial name
- NCT04247906
- Testing
- Narsoplimab
- Sponsor
- Omeros Corporation
Contraception
Integrating Family Planning With Immunization to Improve Maternal and Child Health
The proposed project will help in assessing the effectiveness of a demand-side financing project that provides family planning services bundled in a package of postnatal care and infant immunization services.
- Trial name
- NCT02447913
- Testing
- Voucher
- Where
- Pakistan
- Volunteers
- 28,000 people
- Sponsor
- Greenstar Social Maketing
Osteoarthritis, Avascular Necrosis
Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects
primary endpoint of this Study is maintenance of "at least good clinical status" for a period of 10 years following initial implantation among Cormet procedures enrolled inthe pre-market IDE.
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- Trial name
- PAS:IDE (NCT00721994)
- Testing
- Cormet Hip Resurfacing System
- Where
- 5 sites in United States
- Volunteers
- 231 people
- Sponsor
- Corin
Suicide, Mental Health Disorder
Optimizing a Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents
Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be…
- Conditions
- Suicide, Mental Health Disorder, Anhedonia
- Trial name
- NCT06665620
- Testing
- ViraBrite nudges
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Ksana Health
Renal Cell Carcinoma
Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
The objective of this investigation is to determine the following items in all patients receiving Torisel for a certain period after marketing: 1. Confirmation of efficacy and safety for medical practice use. 2.
- Trial name
- NCT01210482
- Testing
- Temsirolimus
- Where
- Japan
- Volunteers
- 1,050 people
- Sponsor
- Pfizer
Mucopolysaccharidosis (MPS), Hunter Syndrome
A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II)
The main aim of this study is to evaluate the ability of a prophylactic immune tolerizing regimen (ITR) to prevent or reduce the development of high titer anti-idursulfase antibodies in treatment-naïve participants with Hunter…
- Trial name
- NCT05494593
- Testing
- ELAPRASE, Rituximab, Methotrexate
- Where
- 8 sites in United States
- Sponsor
- Takeda
HIV Infection
Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients
The investigation will be conducted for the purpose of determining the condition of occurrence of Adverse Events under the actual post-marketing use of Zithromac 600mg Tablet, verifying the therapeutic effects, detecting unknown…
- Trial name
- NCT01227395
- Testing
- Azithromycin
- Volunteers
- 476 people
- Sponsor
- Pfizer
Melanoma, Adjuvant
Compassionate Use Program BRAF Mutation-positive Patients in the Adjuvant Treatment of Melanoma After Surgical Resection
The purpose of this Treatment Plan is to allow access to trametinib and dabrafenib for eligible high-risk BRAF mutation-positive patients in the adjuvant treatment of melanoma after surgical resection.
- Trial name
- NCT04544202
- Testing
- Dabrafenib and Trametinib, Dabrafenib, Trametinib
- Sponsor
- Novartis Pharmaceuticals
Dravet Syndrome
ZX008 Expanded Access Protocol
The treatment plan for this Expanded Access Protocol is for patients with Dravet syndrome who do not qualify for participation in one of the ongoing ZX008 clinical trials.
- Trial name
- NCT03780127
- Testing
- Fenfluramine Hydrochloride
- Sponsor
- Zogenix, Inc.
Gastrointestinal Stromal Tumors
Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Trial name
- NCT00716820
- Testing
- SUNITINIB MALATE
- Volunteers
- 472 people
- Sponsor
- Pfizer
Neuropathic Pain
Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)
The objective of this investigation is to evaluate the safety and efficacy of long term use with Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will…
- Trial name
- RAINBOW-L (NCT01279850)
- Testing
- Pregabalin (Lyrica) capsule
- Volunteers
- 891 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Carcinoma, Renal Cell
Special Investigation For Renal Cell Carcinoma (RCC) Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan)
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Trial name
- NCT00716625
- Testing
- sunitinib malate
- Volunteers
- 1,674 people
- Sponsor
- Pfizer