Clinical trials: Deficiency Disease
Infection, Human Immunodeficiency Virus I, HIV-1 Infection
HIV-1 Infection Study of Once a Day Versus Twice a Day Protease Inhibitor in Antiretroviral Treatment Naive Adults
This is a Phase IIIB, 48 Week, multicentre, randomized, open-label, parallel group study comparing the safety and efficacy of fosamprenavir plus ritonavir 1400mg/100mg once-daily to fosamprenavir plus ritonavir 700mg/100mg…
- Trial name
- NCT00450580
- Testing
- fosamprenavir/ritonavir
- Where
- 69 sites in Belgium, France and 7 more
- Volunteers
- 212 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics of saquinavir and ritonavir at steady state following administration of saquinavir/ritonavir 1000mg/100mg po bid in HIV patients.
- Trial name
- NCT00435929
- Testing
- Ritonavir, saquinavir [Invirase]
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 16 people
- Sponsor
- Hoffmann-La Roche
Acquired Immunodeficiency Syndrome, HIV Infections
Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse…
- Trial name
- NCT01495702
- Testing
- NNRTI, FTC/TDF, Stribild
- Where
- 80 sites in United States, Australia and 10 more
- Volunteers
- 439 people
- Sponsor
- Gilead Sciences
Melanoma, Hepatocellular Carcinoma (HCC)
Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors
The purpose of this study is to characterize the safety, tolerability, PK, and efficacy of INCB 99280 in combination with ipilimumab in participants with select solid tumors.
- Conditions
- Melanoma, Hepatocellular Carcinoma (HCC), Renal Cell Carcinoma (RCC), Microsatellite Instability - High (MSI-H)
- Trial name
- NCT05909995
- Testing
- INCB 99280 with Ipilimumab
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 8 people
- Sponsor
- Incyte Corporation
Iron Deficiency Anaemia, Inflammatory Bowel Disease
Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1)
The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with non-active ulcerative colitis (UC).
- Conditions
- Iron Deficiency Anaemia, Inflammatory Bowel Disease, Ulcerative Colitis
- Trial name
- AEGIS-1 (NCT01340872)
- Testing
- ST10-021
- Volunteers
- 128 people
- Sponsor
- Shield Therapeutics
AIDS/HIV - RelatedDisease Associated With AIDS, Vaccine-Preventable Diseases
Study to Evaluate the Safety and Immunogenicity of an HIV-1 Vaccine Regimen of Adjuvanted UVAX-1107 Followed by Adjuvanted UVAX-1107 or Adjuvanted UVAX-1197 in Healthy Subjects Aged 25-55 Years.
This is a first in human testing of novel HIV-1 protein nanoparticles vaccine candidates, UVAX-1107 and UVAX-1197 mixed with Aluminum Hydroxide (AH) and CpG 1018 adjuvants.
- Conditions
- AIDS/HIV - RelatedDisease Associated With AIDS, Vaccine-Preventable Diseases, HIV Infections
- Trial name
- NCT06541093
- Testing
- UVAX-1107, UVAX-1197
- Where
- Australia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Uvax Bio LLC
To Determine Bioequivalence Under Fed Conditions
Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions
To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)
- Trial name
- NCT00652704
- Testing
- Doxycycline monohydrate, Monodox
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
HIV-1-infection
Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART)
The purpose of this study is to demonstrate the effectiveness of Symtuza® in a rapid reinitiation model of care in patients with HIV-1 infection and who are treatment-experienced but have been off of antiretroviral therapy (ART)…
- Trial name
- ReSTART (NCT04388904)
- Testing
- Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC)
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- The Crofoot Research Center, Inc.
Fed
Galantamine Bioequivalence Study of Dr. Reddy's Under Fed Condition
Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fed condition.
- Trial name
- NCT01372306
- Testing
- Reminyl
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
HIV Infections
A Phase I Multiple Dose Pharmacokinetic Study of Nevirapine Extended Release (XR) in HIV-1 Infected Children.
The primary objective is to establish the pharmacokinetic (PK) profile at steady state of nevirapine XR in HIV infected children from >=3 to <18 years of age.
- Trial name
- NCT00905489
- Testing
- Nevirapine Immediate Release (IR), Nevirapine Extended Release (XR)
- Where
- 10 sites in United States, Botswana and 2 more
- Volunteers
- 85 people
- Sponsor
- Boehringer Ingelheim
Dwarfism, Pituitary
Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen®
This is an open-label, prospective, multicentric, non-comparative, non-randomized Phase IV interventional study in which subjects pre-diagnosed with Growth Hormone Deficiency (GHD) were treated for 4 weeks with Saizen to compare…
- Trial name
- NCT01187550
- Testing
- Recombinant human growth hormone (r-hGH)
- Volunteers
- 214 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
HIV Infections
A Randomized, Open-Label Study of Alternative Treatment Combinations of Dideoxycytidine (HIVID; ddC) and Zidovudine (AZT) in Patients With HIV Infection
To investigate the appropriate zalcitabine ( dideoxycytidine; ddC ) dose and zidovudine ( AZT ) schedule for use in combination therapy in patients with HIV infection.
- Trial name
- NCT00002117
- Testing
- Zidovudine, Zalcitabine
- Where
- 24 sites in United States
- Volunteers
- 528 people
- Sponsor
- Hoffmann-La Roche
Lysosomal Acid Lipase Deficiency, Cholesterol Ester Storage Disease
Lysosomal Acid Lipase (LAL) Deficiency Registry
This is an observational, multi-center, international disease registry designed to collect longitudinal data and create a knowledge base that will be utilized to improve the care and treatment of patients with LAL Deficiency.
- Conditions
- Lysosomal Acid Lipase Deficiency, Cholesterol Ester Storage Disease, Wolman Disease, Acid Cholesteryl Ester Hydrolase Deficiency, Type 2
- Trial name
- ALX-LALD-501 (NCT01633489)
- Where
- 104 sites in United States, Australia and 20 more
- Volunteers
- 300 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Renal Insufficiency, Chronic, Iron-Deficiency Anemia
Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease
To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD
- Trial name
- AEGIS-CKD (NCT02968368)
- Testing
- Ferric maltol
- Where
- 27 sites in United States
- Volunteers
- 167 people
- Sponsor
- Shield Therapeutics
Pneumonia, Pneumocystis Carinii, HIV Infections
A Study of Trimetrexate Plus Leucovorin in Children With Pneumocystis Carinii Pneumonia
To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in pediatric patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening…
- Trial name
- NCT00002317
- Testing
- Trimetrexate glucuronate, Leucovorin calcium
- Where
- United States
- Sponsor
- U.S. Bioscience
Infection, Human Immunodeficiency Virus I, HIV Infection
Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)
This study will assess the efficacy of subsequent protease inhibitor (PI)-containing therapy in subjects who have acquired HIV-1 protease mutations whilst receiving a GW433908 (fosamprenavir)-containing regimen.
- Trial name
- NCT00242840
- Testing
- No intervention; Observational study
- Where
- 7 sites in United States, Italy
- Volunteers
- 20 people
- Sponsor
- ViiV Healthcare
Glycogen Storage Disease Type II
A Study of the Safety and Efficacy of rhGAA in Patients With Infantile-onset Pompe Disease
Pompe disease (also known as glycogen storage disease type II, "GSD-II") is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA).
- Trial name
- NCT00059280
- Testing
- Myozyme
- Where
- 8 sites in United States, France and 3 more
- Volunteers
- 16 people
- Sponsor
- Genzyme, a Sanofi Company
Infertility
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
The purpose of this study is to assess the efficacy and safety of follitropin alfa/lutropin alfa in Japanese participants with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency undergoing Assisted…
- Trial name
- NCT07340827
- Testing
- Follitropin alfa/lutropin alfa (MBJ-0011), hMG, Cetrorelix acetate
- Where
- 21 sites in Japan
- Volunteers
- 266 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Hereditary Angioedema
Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients
This open-label study is being conducted to confirm the safety, pharmacokinetic profile and efficacy of Ruconest at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in patients, from 2 up to and including…
- Trial name
- NCT01359969
- Testing
- rhC1INH
- Where
- 16 sites in United States, Czechia and 8 more
- Volunteers
- 57 people
- Sponsor
- Pharming Technologies B.V.
Iron Deficiency Anemia
To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency Anaemia
The primary objective is to demonstrate the efficacy of ferric carboxymaltose (FCM) given in a simple dosing regimen in correcting iron deficiency anaemia (IDA), by demonstrating non-inferiority to treatment with the currently…
- Trial name
- NCT03591406
- Testing
- Ferric carboxymaltose, Iron sucrose
- Where
- China
- Volunteers
- 371 people
- Sponsor
- Vifor (International) Inc.