Clinical trials: sponsored by Takeda
Ulcerative Colitis
Long-Term Safety Of PF-00547659 In Ulcerative Colitis
Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.
- Trial name
- TURANDOT II (NCT01771809)
- Testing
- 75mg SHP647 (PF-00547659), 225mg SHP647 (PF-00547659)
- Where
- 99 sites in United States, Australia and 19 more
- Volunteers
- 330 people
- Sponsor
- Shire
Hereditary Angioedema (HAE)
Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks
The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of two doses of CINRYZE with recombinant human hyaluronidase (rHuPH20) administered by subcutaneous (SC) injection to prevent angioedema…
- Trial name
- NCT01756157
- Testing
- CINRYZE with rHuPH20
- Where
- 23 sites in United States, Germany and 2 more
- Volunteers
- 47 people
- Sponsor
- Shire
Hereditary Angioedema (HAE)
CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12
The objectives of this study were to evaluate: (1) the dose response and (2) the pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) administration of CINRYZE for the treatment of acute angioedema attacks in…
- Trial name
- NCT01095510
- Testing
- CINRYZE
- Where
- 11 sites in United States, Germany and 1 more
- Volunteers
- 9 people
- Sponsor
- Shire
Hypoparathyroidism
Use of NPSP558 in the Treatment of Hypoparathyroidism
Use of PTH (1-84) a recombinant hormone in escalating doses for the treatment of adults with hypoparathyroidism. The use of PTH should result in a decrease of calcium and vitamin D supplements.
- Trial name
- REPLACE (NCT00732615)
- Testing
- NPSP558
- Where
- 31 sites in United States, Belgium and 6 more
- Volunteers
- 124 people
- Sponsor
- Shire
Healthy Volunteers
Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects
The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability and pharmacodynamics (PD) of lanadelumab in healthy adult Japanese subjects and matched non-Hispanic healthy adult Caucasian subjects.
- Trial name
- NCT03401671
- Testing
- Lanadelumab
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Shire
Leukodystrophy, Globoid Cell
An Observational Study of Pediatric Subjects With Globoid Cell Leukodystrophy (GLD)
The objective of this study is to evaluate the natural history of disease progression in infants with globoid cell leukodystrophy (GLD).
- Trial name
- NCT01093105
- Sponsor
- Shire
Hereditary Angioedema (HAE)
Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers
This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of icatibant administered to adult Japanese subjects.
- Trial name
- NCT02045264
- Testing
- Icatibant (30 mg)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Shire
Negative Symptoms of Schizophrenia
SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia
To assess the safety and efficacy of SPD489 low-dose and high-dose treatment groups to placebo when given as adjunctive therapy to antipsychotic medication in clinically stable adults with persistent predominant negative symptoms…
- Trial name
- NSS (NCT01234298)
- Testing
- SPD489 Low-Dose, SPD489 High-Dose
- Sponsor
- Shire
Attention-Deficit/Hyperactivity Disorder
The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
This is a phase 2, randomized, multi-center, double-blind, 3-period and 3-treatment crossover study designed to evaluate the safety and duration of efficacy of SPD465 (50 or 75 mg) compared with placebo and an immediate release…
- Trial name
- NCT00928148
- Testing
- SPD465, Immediate Release Amphetamine Salt
- Volunteers
- 86 people
- Sponsor
- Shire
Hereditary Angioedema (HAE)
Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE)
The purpose of this study is to determine if an investigational treatment is safe and well tolerated when administered by intravenous (IV) infusion in Japanese subjects with HAE.
- Trial name
- NCT02865720
- Testing
- CINRYZE 500 U, CINRYZE 1000 U
- Where
- 10 sites in Japan
- Volunteers
- 8 people
- Sponsor
- Shire
Friedreich's Ataxia
Safety and Pharmacology Study of VP 20629 in Adults With Friedreich's Ataxia
The objectives of the study are: To evaluate the safety and tolerability of single and multiple oral doses of VP 20629 in subjects with Friedreich's ataxia (FA).
- Trial name
- NCT01898884
- Testing
- VP 20629
- Where
- 5 sites in United States
- Volunteers
- 46 people
- Sponsor
- Shire
Healthy
Pharmacokinetics of Granule and Tablet Formulations of Deferitazole (Disodium Salt) and a Capsule Formulation of Deferitazole (Magnesium Hydroxide Salt)
The purpose of this study is to compare the pharmacokinetic profiles of deferitazole after administration of granule and tablet formulations of a deferitazole disodium salt to a capsule formulation of deferitazole magnesium…
- Trial name
- NCT02065401
- Testing
- Deferitazole (disodium salt, granule), Deferitazole (disodium salt, tablet), Deferitazole (magnesium hydroxide salt)
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Shire
Hereditary Angioedema (HAE)
Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE.
- Trial name
- NCT02586805
- Testing
- DX-2930 - 300mg/2wk, DX-2930 - 300mg/4wk, DX-2930 - 150mg/4wk
- Where
- 41 sites in United States, Canada and 5 more
- Volunteers
- 125 people
- Sponsor
- Shire
Cytomegalovirus (CMV)
Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients
This study will assess safety, antiviral activity, and pharmacokinetics of different doses of maribavir administered orally for up to 24 weeks for treatment of CMV infections that are resistant or refractory to treatment with…
- Trial name
- NCT01611974
- Testing
- Maribavir
- Where
- 32 sites in United States
- Volunteers
- 120 people
- Sponsor
- Shire
Transfusional Iron Overload, Iron Overload
Treatment of Iron Overload Requiring Chelation Therapy
The purpose of this open-label study is to assess liver iron concentration using MRI imaging in subjects with beta-thalassemia when administered with either SPD602 or deferasirox for the treatment of chronic transfusional iron…
- Conditions
- Transfusional Iron Overload, Iron Overload, Iron Chelation, Beta-thalassemia
- Trial name
- NCT01927913
- Testing
- SPD602, Deferasirox
- Sponsor
- Shire
Healthy Volunteers, Tension-type Headache
A Study to Describe Pain Intensity, Pain Relief and Safety of Neosaldina in the Treatment of Tension-type Headaches (TTH) in Healthy Participants
The purpose of this study is to describe pain relief in TTH with Neosaldina treatment.
- Trial name
- NCT03666858
- Where
- 5 sites in Brazil
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Takeda
Short Bowel Syndrome
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.
- Trial name
- NCT00172185
- Testing
- teduglutide 0.05 mg/kg/d, teduglutide 0.10 mg/kg/d
- Where
- 21 sites in United States, Belgium and 6 more
- Volunteers
- 65 people
- Sponsor
- Shire
Attention Deficit Hyperactivity Disorder (ADHD)
Efficacy and Safety of SHP465 at 6.25 mg in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-12 Years
The purpose of this study is to evaluate the efficacy and safety of SHP465 at 6.25 mg in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6-12 years.
- Trial name
- NCT03325881
- Testing
- SHP465
- Where
- 41 sites in United States
- Volunteers
- 89 people
- Sponsor
- Shire
Thrombocythemia, Hemorrhagic
A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients
Essential thrombocythaemia is a disorder of bone marrow, which causes too many platelets to be produced. Platelets are small cells carried around in the blood, which help form blood clots.
- Trial name
- NCT00202644
- Testing
- Anagrelide, Hydroxyurea
- Where
- 15 sites in Bulgaria, France and 4 more
- Volunteers
- 150 people
- Sponsor
- Shire
Crohn Disease, Ulcerative Colitis
Characterization of CD Responders to Vedolizumab
The purpose of this study is to characterize which patients with Crohn's disease are likely to respond to standard of care to vedolizumab therapy.
- Trial name
- NCT04909359
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- University of Miami
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