Clinical trials: Amino Acids
Phenylketonuria, PKU
Rapid Drug Desensitization Study in Adults Experiencing Hypersensitivity Reactions to Palynziq
The purpose of this study is to determine if rapid drug desensitization (RDD) to Palynziq will improve drug tolerability and treatment persistence in adult patients on commercial Palynziq experiencing hypersensitivity reactions…
- Trial name
- PALLADIUM (NCT06780332)
- Testing
- RDD to Palynziq
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- BioMarin Pharmaceutical
Urea Cycle Disorders
Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs)
This non-randomized, open-label study was approximately one year in duration and consisted of a short term NaPBA to HPN-100 switchover part involving two overnight stays followed by a 12-month long term treatment period involving…
- Trial name
- NCT01347073
- Testing
- HPN-100
- Where
- 8 sites in United States
- Volunteers
- 23 people
- Sponsor
- Amgen
Phenylketonurias
Evaluation of Low Phenylalanine Formulas
Ajinomoto Cambrooke has developed a PKU protein substitute that is a proprietary blend of purified Glycomacropeptide (GMP) and essential amino acids, under the brand name Glytactin®.
- Trial name
- NCT06332105
- Testing
- Glytactin, L-AA
- Where
- 2 sites in United Kingdom
- Volunteers
- 19 people
- Sponsor
- Ajinomoto Co., Inc.
Arginase I Deficiency, Hyperargininemia
A Study of AEB1102 (Pegzilarginase) in Patients With Arginase 1 Deficiency
The purpose of this study is to determine the safety, tolerability, and efficacy of long-term intravenous and subcutaneous administration of pegzilarginase for the treatment of pediatric and adult patients with ARG1-D who…
- Trial name
- NCT03378531
- Testing
- AEB1102
- Where
- 7 sites in United States, Canada and 2 more
- Volunteers
- 14 people
- Sponsor
- Immedica Pharma AB
Ornithine Transcarbamylase Deficiency
Study to Characterize Rate of Ureagenesis in Patients With Ornithine Transcarbamylase (OTC) Deficiency
The objectives of the study are to characterize urea production rates in patients with OTC, characterize the association of rate of ureagenesis and disease severity in OTC patients, characterize the association of rate of…
- Trial name
- NCT04717453
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Phenylketonuria
Safety and Therapeutic Effects of Sapropterin Dihydrochloride on Neuropsychiatric Symptoms in Phenylketonuria (PKU) Patients
This double-blind, placebo-controlled, randomized study is designed to evaluate the safety and therapeutic effects of sapropterin dihydrochloride on neuropsychiatric symptoms in subjects with PKU.
- Trial name
- NCT01114737
- Testing
- Sapropterin dihydrochloride
- Where
- 36 sites in United States, Canada
- Volunteers
- 206 people
- Sponsor
- BioMarin Pharmaceutical
Healthy Resistance-Trained Males
Comparison of Plant and Animal Proteins on Amino Acid Concentrations
The study purpose is to assess various protein blends, which differ in protein quality, and the impact on blood amino acid response in male subjects.
- Trial name
- NCT03673839
- Testing
- Animal Proteins (crossover), Plant-based protein blends type 1 (crossover), Plant-based protein blends type 2 (crossover)
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Danone North America
Urea Cycle Disorders
Study of the Safety and Tolerability of HPN-100 Compared to Sodium Phenylbutyrate in Children With Urea Cycle Disorders
Protocol HPN-100-005 was the first study of HPN-100 in pediatric subjects with urea cycle disorders (UCDs) and was a fixed-sequence, open-label, switch over study of HPN-100 with a long-term (12 month) safety extension designed…
- Trial name
- NCT00947544
- Testing
- HPN-100, NaPBA
- Where
- 8 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- Amgen
Metastatic Pancreatic Adenocarcinoma, Locally Advanced Unresectable Pancreatic Adenocarcinoma
Medical Food for the Dietary Management of Advanced/Metastatic Pancreatic Cancer
This is a single arm study evaluating the tolerability and markers of pancreatic cancer with a specially designed medical food restricted in specific amino acids for the dietary management of subjects with locally advanced and…
- Trial name
- NCT05078775
- Testing
- NEAAR Medical Food
- Where
- 9 sites in United States
- Volunteers
- 39 people
- Sponsor
- Faeth Therapeutics
Phenylketonuria, PAH Deficiency
Long-Term Follow Up Study of Subjects Previously Administered HMI 102
An Open-Label, Long-Term Follow Up Study of Safety and Efficacy in PKU Subjects with PAH Deficiency Previously Administered HMI 102
- Trial name
- NCT04348708
- Testing
- HMI-102
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Homology Medicines, Inc
Phenylketonuria
Sapropterin Expanded Access Program
The Purpose of this study is to provide patients with hyperphenylalaninemia (HPA) due to Phenylketonuria (PKU) access to sapropterin dihydrochloride and to collect more information about the safety of the drug in an expanded…
- Trial name
- NCT00484991
- Testing
- Sapropterin dihydrochloride
- Where
- 36 sites in United States
- Sponsor
- BioMarin Pharmaceutical
Inflammatory Bowel Diseases, Short Bowel Syndrome
Effects of an Amino Acid Mixture on Gastrointestinal Function, Inflammation and Fluid Balance: A Pilot Study in Patients With Inflammatory Bowel Disease
This pilot study will examine the benefit of this amino acid based hydration solution in patients with IBD who have undergone a total colectomy and have either ileostomies or jpouches.
- Conditions
- Inflammatory Bowel Diseases, Short Bowel Syndrome, Ileostomy - Stoma
- Trial name
- NCT03451253
- Testing
- amino acid mixture beverage, glucose-based sports drink
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Entrinsic Bioscience Inc.
Infant Development
Acceptability and Tolerance Study of an Amino Acid Formula with HMOs
To evaluate the acceptability (including gastrointestinal tolerance and compliance) of a hypoallergenic amino acid infant formula with HMOs for the dietary management of cows' milk allergy in infants less than 12 months of age.
- Trial name
- NCT04575298
- Testing
- Acceptability, tolerance study for an infant formula with human milk oligosaccharides
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Société des Produits Nestlé (SPN)
Phenylketonuria, Inborn Errors of Metabolism
Evaluation of PKU Start
To evaluate the acceptability, tolerance and effect on metabolic control of PKU Start, a new Phe free protein substitute for the dietary management of PKU in infants from birth.
- Trial name
- PKU Start (NCT03058848)
- Testing
- PKU Start
- Where
- 3 sites in United Kingdom
- Volunteers
- 10 people
- Sponsor
- Vitaflo International, Ltd
Healthy Male Volunteers
Bioavailability of Pea Protein in Young and Old Volunteers
The aim of this study done in healthy, non-malnourished young and elderly subjects, is to measure the bioavailability of protein intake and the variation of metabolic markers following consumption of pea protein " NUTRALYS ® S85…
- Trial name
- NUTRALYS (NCT06381869)
- Testing
- Pea protein (NUTRALYS ® S85 plus) in water, Pea protein (NUTRALYS ® S85 plus) within meal, Whey protein in water
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Roquette Freres
Vitiligo, Piebaldism
Evaluation of Non-cultured Epidermal Cellular Grafting vs Hyaluronic Acid for Repigmenting Vitiligo and Piebaldism
The purpose of this study is to assess the efficacy of autologous epidermal cells suspension grafting using a newly developed device named VITICELL® compared to placebo.
- Trial name
- NCT02156427
- Testing
- VITICELL
- Where
- 5 sites in Belgium, France and 1 more
- Volunteers
- 38 people
- Sponsor
- Laboratoires Genévrier
Cytomegalovirus Infections, Cytomegalovirus Retinitis
Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
To make intravenous (IV) ganciclovir available to immunocompromised patients with life-threatening or sight-threatening Cytomegalovirus (CMV) infection, where the symptoms of the disease are too severe to allow admission to a…
- Conditions
- Cytomegalovirus Infections, Cytomegalovirus Retinitis, HIV Infections
- Trial name
- NCT00002025
- Testing
- Ganciclovir
- Where
- United States
- Sponsor
- Hoffmann-La Roche
Phenylketonuria
A Long-Term Safety Study of PTC923 in Participants With Phenylketonuria
The main purpose of this study is to evaluate the long-term safety of PTC923 in participants with phenylketonuria, and to evaluate the changes from baseline in dietary phenylalanine (Phe)/protein consumption.
- Trial name
- NCT05166161
- Testing
- PTC923
- Where
- 46 sites in United States, Australia and 17 more
- Volunteers
- 247 people
- Sponsor
- PTC Therapeutics
Phenylketonuria
Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)
SYNB1934-CP-003 was designed as a 3-part, adaptive study consisting of a dose-escalating, open-label period (DEP; Part 1) of up to 15 weeks, followed by a 4-week, double-blind, placebo-controlled, randomized withdrawal period…
- Trial name
- SYNPHENY-3 (NCT05764239)
- Testing
- SYNB1934v1
- Where
- 21 sites in United States, Canada and 2 more
- Volunteers
- 35 people
- Sponsor
- Synlogic
Hereditary Tyrosinemia, Type I
Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Nitisinone in HT-1
The purpose of this study is to look at the steady-state serum concentrations of nitisinone when switching from twice daily and once daily dosing.
- Trial name
- HT-1 (NCT02323529)
- Testing
- Nitisinone
- Where
- 6 sites in Belgium, Denmark and 3 more
- Volunteers
- 18 people
- Sponsor
- Swedish Orphan Biovitrum