Clinical trials: Injection Drug Use
Multiple Sclerosis
Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) "Prevention of Relapse of Multiple Sclerosis"
The purpose of this study is to evaluate the safety and efficacy of Copaxone subcutaneous injection syringe (hereinafter referred to as Copaxone) in patients with multiple sclerosis in the routine clinical setting.
- Trial name
- NCT03209479
- Testing
- Glatiramer acetate
- Where
- Japan
- Volunteers
- 1,332 people
- Sponsor
- Teva Takeda Pharma Ltd.
Lymphoma, T-Cell, Peripheral
ISTODAX® for Intravenous Infusion Drug Use Results Survey- Relapsed or Refractory Peripheral T-Cell Lymphoma
To ascertain the safety and efficacy of Istodax® in actual clinical settings in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who receive Istodax. 1. Planned registration period 4 years 2.
- Trial name
- NCT03742921
- Testing
- Istodax
- Where
- Japan
- Volunteers
- 150 people
- Sponsor
- Celgene
Systemic Lupus Erythematosus
BENLYSTA® Special Drug Use Investigation
The objective of this study is to collect and assess the information about long-term safety and effectiveness of Benlysta for intravenous injection and Benlysta for subcutaneous injection (hereinafter referred to as "Benlysta")…
- Trial name
- NCT03370263
- Testing
- Benlysta
- Where
- Japan
- Volunteers
- 1,514 people
- Sponsor
- GlaxoSmithKline
Short Bowel Syndrome
A Study of Teduglutide in Japanese People With Short Bowel Syndrome
The main aims of this study are to check for side effects from treatment with teduglutide (Revestive) and how well teduglutide controls symptoms of short bowel syndrome.
- Trial name
- NCT05023382
- Testing
- Teduglutide
- Where
- Japan
- Volunteers
- 250 people
- Sponsor
- Takeda
Anovulation
Protocol for Drug Use Investigation of Follistim Injection (Study P06132)(COMPLETED)
The main purpose of this investigation is to collect information about safety and efficacy of Follistim Injection from actual clinical use to induce ovulation in patients with anovulation and oligoovulation due to…
- Trial name
- NCT00920634
- Testing
- Follitropin beta
- Volunteers
- 384 people
- Sponsor
- Organon and Co
Fertilization in Vitro
Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)
To evaluate dosage and administration method, efficacy and safety of Puregon and the relationship between background factors of patients and dose and administration method.
- Trial name
- NCT00920361
- Testing
- Follitropin beta
- Volunteers
- 1,664 people
- Sponsor
- Organon and Co
Opioid Overdose, Opioid Use Disorder
Safety, Tolerability, and Pharmacokinetics of CSX-1004
This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion across a range of doses in healthy adult…
- Trial name
- NCT06005402
- Testing
- CSX-1004
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cessation Therapeutics, Inc.
Cryopyrin-Associated Periodic Syndromes
Kineret CAPS Post Authorisation Study
A non-interventional, post authorization safety study to evaluate the safety of Kineret in the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with regard to serious infections, malignancies…
- Trial name
- NCT02326376
- Testing
- anakinra (Kineret)
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 12 people
- Sponsor
- Swedish Orphan Biovitrum
Cardiovascular Disease
Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg
The objective of this study is to evaluate the incidence of adverse events in Japanese pulmonary arterial hypertension subjects treated with epoprostenol injection based on prescribing information under the conditions of general…
- Trial name
- NCT01387191
- Testing
- Epoprostenol
- Volunteers
- 748 people
- Sponsor
- GlaxoSmithKline
Life Threatening Bleeding, Factor Xa Inhibitor
Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation)
This survey will be conducted to investigate the status of occurrence of the safety specifications set for "Safety specification" in patients who received Ondexxya Intravenous Injection 200 mg.
- Trial name
- NCT05454787
- Where
- 54 sites in Japan
- Volunteers
- 300 people
- Sponsor
- AstraZeneca
Neovascular Age-related Macular Degeneration (nAMD)
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit
This is a single-arm, open-label study where all patients will receive a single injection of SOK583A1 (40 mg/mL) provided in a vial kit at Baseline. The total study duration for the individual participant is approximately 31 days.
- Trial name
- NCT05282004
- Testing
- SOK583A1
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Sandoz
Prostate Cancer
Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"
The purpose of this survey is designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate SR 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit) in prostate cancer…
- Trial name
- NCT02167893
- Testing
- Leuprorelin acetate
- Volunteers
- 11,288 people
- Sponsor
- Takeda
Acquired Hemophilia A
A Study of OBIZUR in Adults With Acquired Hemophilia A (AHA) in South Korea
Acquired hemophilia A (AHA) is a rare bleeding condition which prevents blood clotting. Acquired means that people are not born with this condition or have a family history of blood clotting conditions.
- Trial name
- NCT06550882
- Testing
- OBIZUR
- Where
- 4 sites in South Korea
- Volunteers
- 9 people
- Sponsor
- Takeda
Protein C Deficiency
A Study of Freeze-dried Human Protein C Concentrate (TAK-662) in Participants With Congenital Protein C Deficiency
This study is conducted in Japan of Freeze-dried Human Protein C Concentrate (TAK-662) used to treat participants with congenital protein C deficiency.
- Trial name
- NCT06590974
- Testing
- Freeze-dried Human Protein C Concentrate
- Where
- Japan
- Volunteers
- 7 people
- Sponsor
- Takeda
Inflammatory Bowel Diseases, Colitis, Ulcerative
A Study of Kynteles Injection (Vedolizumab) in Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease or Chronic Pouchitis
In this study, participants with ulcerative colitis or Crohn's disease or pouchitis will be treated with Kynteles injection (Vedolizumab) according to their clinic's standard practice.
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
- Trial name
- NCT04799496
- Where
- 43 sites in South Korea
- Volunteers
- 688 people
- Sponsor
- Takeda
SARS-CoV-2 Infection
Evusheld Japan PMS_Japan Post-Marketing Surveillance (PMS)
To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese.
- Trial name
- NCT05687877
- Where
- 18 sites in Japan
- Volunteers
- 366 people
- Sponsor
- AstraZeneca
Acute Lymphocytic Leukemia
BESPONSA Injection 1 mg Special Investigation
The purpose of this study is to learn about the safety and effectiveness of BESPONSA. BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia.
- Trial name
- NCT05923112
- Where
- Japan
- Volunteers
- 421 people
- Sponsor
- Pfizer
Opioid Use Disorder
Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations
Extended-release buprenorphine (SUBLOCADE®) injection is currently approved for subcutaneous administration in the abdomen for treatment of opioid use disorder (OUD).
- Trial name
- NCT05704543
- Testing
- Buprenorphine Extended-Release Injection
- Where
- 6 sites in United States
- Volunteers
- 132 people
- Sponsor
- Indivior Inc.
Diabetic Macular Edema
Chart Review: Drug Utilization Study in Participants Who Received Ozurdex™ (Dexamethasone Intravitreal Implant) 0.7 mg Injections for Visual Impairment Due to Diabetic Macular Edema (DME)
A retrospective, non-interventional, observational, multi-center, drug utilization study to be conducted in adult participants with visual impairment due to DME treated with Ozurdex implants in Germany and Switzerland from 1…
- Trial name
- NCT03889444
- Testing
- Dexamethasone intravitreal implant
- Where
- United States
- Volunteers
- 141 people
- Sponsor
- Allergan
Prostate Cancer
Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"
The purpose of this study is to evaluate the safety in patients with prostate cancer receiving the drug in the routine clinical setting.
- Trial name
- NCT03209492
- Testing
- Leuprorelin acetate
- Where
- Japan
- Volunteers
- 333 people
- Sponsor
- Takeda