Clinical trials: Deficiency Disease
HIV-1
A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years
The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen…
- Trial name
- NCT00799864
- Testing
- Rilpivirine, Zidovudine, Abacavir
- Where
- 17 sites in United States, India and 6 more
- Volunteers
- 54 people
- Sponsor
- Janssen Sciences Ireland UC
Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants
The primary objectives of this study are to evaluate the safety, tolerability and steady-state PK and confirm the dose of EVG/r in HIV-1 infected, antiretroviral treatment-experienced children 4 weeks to <18 years of age.
- Trial name
- NCT01923311
- Testing
- EVG, Background regimen
- Where
- 11 sites in United States, Italy and 4 more
- Volunteers
- 31 people
- Sponsor
- Gilead Sciences
Growth Hormone Deficiency
Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers
The study is a Phase 1, randomized, double-blind, vehicle-controlled, single-dose, three dose levels study in healthy Caucasian and Japanese male volunteers.
- Trial name
- NCT02418767
- Testing
- MOD-4023
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- OPKO Health, Inc.
Alpha Mannosidosis
Dose Finding Study of Recombinant Human Alpha-mannosidase for the Treatment of Patients With Alpha-mannosidosis
This is a single-center, open-label, multiple-dose study of the efficacy and long-term safety of Lamazym for the treatment of patients with alpha-mannosidosis.
- Trial name
- NCT01285700
- Testing
- Lamazym
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Zymenex A/S
Pneumonia, Pneumocystis Carinii, HIV Infections
A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)
To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening toxicities to…
- Trial name
- NCT00002434
- Testing
- Trimetrexate glucuronate, Leucovorin calcium
- Where
- United States
- Sponsor
- U.S. Bioscience
Infection, Human Immunodeficiency Virus, HIV Infections
Phase 4 Study of Dolutegravir (DTG) in Russian Federation
DTG 50 milligram (mg) tablet was approved for marketing in Russian Federation; however, DTG is not currently available for subjects at Acquired Immune Deficiency Syndrome (AIDS) Centers as it is not available for order and supply…
- Trial name
- NCT03314064
- Testing
- Dolutegravir 50 mg
- Where
- 11 sites in Russia
- Volunteers
- 43 people
- Sponsor
- ViiV Healthcare
Hereditary Angioedema (HAE), Hereditary Angioedema - Type 1
Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)
Study ADX-324-302 is an extension study for participants who complete the Phase 3 ADX-324-301 trial. The extension study will provide information about the safety and efficacy of additional dosing of ADX-324 in participants with…
- Conditions
- Hereditary Angioedema (HAE), Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, HAE
- Trial name
- NCT07428499
- Testing
- ADX-324 Dose Level 1, ADX-324 Dose Level 2
- Where
- 48 sites in United States, Argentina and 17 more
- Volunteers
- 90 people
- Sponsor
- ADARx Pharmaceuticals, Inc.
Infection, Human Immunodeficiency Virus
Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects
This study will be a phase I, open label, three period, fixed sequence crossover study to evaluate the effect of Carbamazepine (CBZ) on the steady-state pharmacokinetics of Dolutegravir (DTG) and on the safety and tolerability of…
- Trial name
- NCT01967771
- Testing
- DTG, CBZ
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus
Bioavailability of BMS-626529 in Healthy Subjects From Prototype Low Dose Extended Release Formulations (Part 1) and Prototype Extended Release Multi-particulate Formulations (Part 2) of BMS-663068 Relative to 600 mg Extended Release Tablet
This 2-part study will determine the bioavailability of BMS-626529 in healthy subjects from prototype low dose extended release formulations (Part 1) of BMS-663068 and prototype extended release multi-particulate formulations…
- Trial name
- NCT02508064
- Testing
- BMS-663068
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Primary Immunodeficiency Disease
An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease
This study is an extension study for participants with primary immunodeficiency disorders who were previously treated with IGSC, 20% in the TAK-664-3001 study.
- Trial name
- NCT04842643
- Testing
- IGSC 20% infusion
- Where
- 8 sites in Japan
- Volunteers
- 12 people
- Sponsor
- Takeda
Hereditary Angioedema
EASSI - Evaluation of the Safety of Self-Administration With Icatibant
This study is being conducted to explore the clinical safety, local tolerability, convenience and effectiveness of self-treatment of hereditary angioedema (HAE) attacks with subcutaneous injections of icatibant.
- Trial name
- EASSI (NCT00997204)
- Testing
- Icatibant
- Where
- 26 sites in Argentina, Austria and 8 more
- Volunteers
- 151 people
- Sponsor
- Shire
HIV Infections
Phase Ib Study of Safety, Tolerability and Pharmacokinetics of Elpida Once Weekly in Healthy Volunteers
A randomized once weekly dose for 8 weeks, study in Healthy HIV-Uninfected Volunteers. Each of 3 parallel groups (40 mg, 80 mg and 160mg) enrolls 12 subjects.
- Trial name
- NCT05204121
- Testing
- Elpida
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Viriom
Colorectal Adenocarcinoma
A Study to Evaluate the Efficacy of VVD-133214 in Combination With Pembrolizumab Compared With Pembrolizumab Alone in Participants With Advanced Cancer of the Colon or Rectum
Researchers are looking for a better way to treat people with advanced colorectal cancer. Colorectal cancer (cancer of the colon or rectum) is one of the most common cancers worldwide.
- Trial name
- NCT07811193
- Testing
- VVD-133214, Pembrolizumab
- Where
- 122 sites in United States, Argentina and 20 more
- Volunteers
- 140 people
- Sponsor
- Vividion Therapeutics, Inc.
Familial Lipoprotein Lipase Deficiency
Efficacy and Safety of Human Lipoprotein Lipase (LPL)[S447X] Expressed by an Adeno-Associated Viral Vector in LPL-deficient Subjects
This trial is designed to expand the currently available data on the safety and efficacy of alipogene tiparvovec treatment in lipoprotein lipase deficiency (LPLD) and to further the understanding of possible mechanisms of action…
- Trial name
- NCT00891306
- Testing
- Alipogene Tiparvovec (AMT-011), Human LPL [S447X], mycophenolate mofetil, cyclosporine
- Where
- 2 sites in Canada
- Volunteers
- 5 people
- Sponsor
- Amsterdam Molecular Therapeutics
Hereditary Angioedema (HAE)
A Study of Navenibart in Participants With Hereditary Angioedema
This is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent participants with type 1 or type 2…
- Trial name
- ALPHA-ORBIT (NCT06842823)
- Testing
- navenibart
- Where
- 86 sites in United States, Australia and 22 more
- Volunteers
- 157 people
- Sponsor
- Astria Therapeutics, Inc.
Hereditary Angioedema (HAE)
Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema
The primary objective of this study is: assess the safety and tolerability of ecallantide in paediatric patients for acute attacks of HAE The secondary objectives are: evaluate the pharmacokinetic profile of ecallantide in…
- Trial name
- NCT01253382
- Testing
- ecallantide
- Sponsor
- Shire
Hereditary Angioedema (HAE)
Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)
The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe acute attacks of HAE.
- Trial name
- NCT00262080
- Testing
- ecallantide, Phosphate Buffer Saline (PBS),
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- Shire
Chronic Heart Failure, Iron-deficiency
Evaluating Iron Protein Succinylate Oral Solution in Treating Chronic Heart Failure and Iron Deficiency
This study aims to evaluate the effect of standard heart failure therapy plus oral solution with protein succinylate iron compared to placebo on the primary end point of 6 minute walk distance at 24th week in patients with…
- Trial name
- NCT03344523
- Testing
- Iron protein succinylate oral solution, standard treatment
- Volunteers
- 600 people
- Sponsor
- Lee's Pharmaceutical Limited
Anemia, Skin Condition
The Efficacy of Minayo Iron-rich Nutritional Gummies on Female Anemia, Skin Condition and Qi-blood Deficiency Syndrome
The goal of this randomized, double-blind, placebo controlled study is to learn about the efficacy of Minayo Iron-rich Nutritional Gummies on females who are aged 18-45 and suffer nutritional Anemia, skin condition and Qi-blood…
- Conditions
- Anemia, Skin Condition, Qi-blood Deficiency Syndrome
- Trial name
- NCT06869824
- Testing
- Minayo Iron-rich Nutritional Gummies, Common Gummies
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Hangzhou Agile Groups Network Technology Co., Ltd.
Fed
Bioequivalence Study of Olanzapine Tablets, 5 mg Under Fed Study
The purpose of this study is to compare the bioequivalence and characterize the profile of the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects under fed conditions and to monitor the adverse…
- Trial name
- NCT01503424
- Testing
- Olanzapine
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
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