Clinical trials: Protein Deficiency
Hypoalbuminemia, Protein-energy Malnutrition
Anit-Inflammatory and Anti-Oxidative Nutrition in Dialysis Patients
Study of efficiency and safety of oral nutritional supplements with anti-inflammatory and antioxidative properties combined with an appetite stimulant with anti-inflammatory properties (pentoxiphylline) in treatment of…
- Conditions
- Hypoalbuminemia, Protein-energy Malnutrition, Inflammation, Oxidative Stress
- Trial name
- AIONID (NCT00561093)
- Testing
- pentoxiphylline, Nepro, anti-inflammatory module (similar to Oxepa)
- Where
- 2 sites in United States
- Volunteers
- 93 people
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
HIV Infections
A Phase I Multicenter Study of the Safety and Immunogenicity of MN rgp120/HIV-1 Vaccine Given Either Alone or in Combination With IIIB rgp120/HIV-1 Vaccine in Healthy Adult Subjects (NOTE: Original Study Extended ONLY for Patients Previously Enrolled on VEU 009)
AMENDED 10/1/93: To evaluate the influence of prior immunization with an rgp120 vaccine on immune response to a subsequent immunization with a different strain of rgp120 (VEU 009X extension - in patients previously enrolled on…
- Trial name
- NCT00001021
- Testing
- rgp120/HIV-1IIIB, rgp120/HIV-1MN
- Where
- 3 sites in United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
CHAPLE Disease
A Study to Test the Safety of Pozelimab in Pediatric Participants 1 to 5 Years of Age With a Rare Disease Called CHAPLE (Complement Hyperactivation, Angiopathic Thrombosis, Protein-losing Enteropathy) Disease
This study is researching a drug called pozelimab (called "study drug"). The main aim of this study is to monitor the safety and tolerability of the study drug.
- Trial name
- NCT07142343
- Testing
- Pozelimab
- Where
- Turkey (Türkiye)
- Volunteers
- 5 people
- Sponsor
- Regeneron Pharmaceuticals
Tuberculosis, Hiv
A One-stop Shop for the Same Day Diagnosis and Management of TB and HIV
TB is a major public health problem and the second most common cause of adult death due to infection in many low-income countries.
- Trial name
- NCT04043390
- Testing
- CRP and Molbio Truenat MTB, CRP and Xpert ULTRA MTB/RIF, standard test Xpert
- Where
- Nigeria
- Volunteers
- 1,100 people
- Sponsor
- Liverpool School of Tropical Medicine
Immunodeficiency
Testing a Novel Dairy Protein to Counteract Immunosenescence
Aging populations experience a decline in adaptive immune system function also known as immunosenesence. Nutritional approaches to stimulate and strengthen the immune system are needed for this growing segment of the population.
- Trial name
- NCT03557463
- Testing
- Dairy protein
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Healthy
Safety, Tolerability and Immunogenicity Study of 2 Dose Levels of Trimeric Glycoprotein140 (gp140) in Healthy Adult Volunteers
The purpose of this study is to assess the safety and tolerability of 2 different dose levels of trimeric glycoprotein140 (gp140) administered as a 2-dosage regimen, intramuscularly (injection of a substance into a muscle), with…
- Trial name
- NCT02304185
- Testing
- gp140, 50 mcg, gp140, 50 mcg + Adjuvant, gp140, 250 mcg
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Hemophilia B
Open-Label Single Ascending Dose of Adeno-associated Virus Serotype 8 Factor IX Gene Therapy in Adults With Hemophilia B
The purpose of this study is to evaluate the safety of single ascending IV doses of a Factor IX (FIX) Gene Therapy in up to 16 Adults with Hemophilia B.
- Trial name
- NCT01687608
- Testing
- AskBio009
- Where
- 15 sites in United States
- Volunteers
- 30 people
- Sponsor
- Baxalta now part of Shire
Hypophosphatasia
Expanded Access Program for Asfotase Alfa Treatment for Patients With Infantile- or Juvenile-onset Hypophosphatasia (HPP)
This clinical trial is being conducted in Hypophosphatasia, a bone disorder caused by gene mutation(s) resulting in bone defects. These gene mutations cause low levels of an enzyme needed to harden bone.
- Trial name
- NCT02496689
- Testing
- asfotase alfa
- Where
- 5 sites in United States, France
- Sponsor
- Alexion Pharmaceuticals, Inc.
HIV Infection
A Phase I, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability and Immunogenicity Study of Candidate HIV-1 Vaccines ChAdOx1.HTI and MVA.HTI With Recombinant HIV-1 Envelope Protein ConM SOSIP.v7 gp140 Vaccine, Adjuvanted With MPLA Liposomes in ART-Suppressed HIV-1 Positive Individuals
BCN03 is a Single-site, randomized, double-blind, placebo-controlled, phase I study to evaluate the safety, tolerability, immunogenicity, and efficacy of a vaccine regimen that includes a sequence of the T- and B-cell immunogens…
- Trial name
- NCT05208125
- Testing
- ChAdOx1.HTI at week 0, ConM SOSIP.v7 at weeks 4, 12 and 28, and MVA.HTI at week 22 (CSSMS)., Normal saline solution
- Where
- Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- IrsiCaixa
HIV Infections
A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Volunteers to Evaluate Accelerated Vaccine Schedules
To evaluate the safety and immunogenicity of an accelerated schedule of recombinant canarypox vaccine ALVAC-HIV MN120TMG (vCP205) versus control followed by boost with rgp120/HIV-1 SF2 vaccine in HIV-negative volunteers.
- Trial name
- NCT00001076
- Testing
- ALVAC-HIV MN120TMG (vCP205), ALVAC-RG Rabies Glycoprotein (vCP65), rgp120/HIV-1 SF-2
- Where
- 3 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Antithrombin III Deficiency
Safety, Pharmacokinetics and Efficacy of an ATIII Concentrate
To assess the safety, pharmacokinetics and efficacy of a plasma-derived AT-III concentrate in the treatment of subjects with congenital AT-III deficiency.
- Trial name
- NCT00319228
- Testing
- Plasma-derived AT-III concentrate
- Volunteers
- 3 people
- Sponsor
- Instituto Grifols, S.A.
HIV Infections, Pregnancy
Active Immunization of HIV-Infected Pregnant Women: A Phase I Study of Safety and Immunogenicity of a rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)
PRIMARY: To evaluate the short-term safety of rgp120/HIV-1SF2 vaccine versus MF59 placebo administered to HIV-infected pregnant women.
- Conditions
- HIV Infections, Pregnancy, HIV Seronegativity
- Trial name
- NCT00001046
- Testing
- MF59, rgp120/HIV-1 SF-2
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Primary Immunodeficiency Disease
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)
The purpose of this study is to assess efficacy, safety and pharmacokinetics of Kedrion Immunoglobulin 10% (KIg10) in pediatric patients with Primary Immunodeficiency Disease (PID).
- Trial name
- KIDCARES10 (NCT04944979)
- Testing
- Kedrion IVIG 10%
- Where
- 21 sites in United States, Hungary and 4 more
- Volunteers
- 30 people
- Sponsor
- Kedrion S.p.A.
Vitamin D Deficiency, Malnutrition
Optimizing Treatment Programs for Chronic Kidney Disease-mineral and Bone Disorder and Malnutrition
Multi-center, prospective, randomized, controlled study to verify the clinical effectiveness of K / DOQI guidelines. The efficiency and safety of Vitamin D2 and low protein diet treatment for prevention and treatment of CKD-MBD…
- Trial name
- NCT02005302
- Testing
- 1,25(OH)2 Vitamin D3, Vitamin D2, low protein diet
- Where
- 5 sites in China
- Volunteers
- 600 people
- Sponsor
- Wenhu Liu
Immunologic Deficiency Syndromes, Chediak-Higashi Syndrome
Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies
OBJECTIVES: I. Provide curative immunoreconstituting allogeneic bone marrow transplantation for patients with primary immunodeficiencies. II.
- Conditions
- Immunologic Deficiency Syndromes, Chediak-Higashi Syndrome, Common Variable Immunodeficiency, Graft Versus Host Disease
- Trial name
- NCT00006054
- Testing
- anti-thymocyte globulin, busulfan, cyclophosphamide
- Where
- United States
- Sponsor
- Fairview University Medical Center
Carrier of Hemophilia A, Desmopressin
Genetic Factors of the Desmopressin Response in Carriers of Hemophilia A
Hemophilia A (HA) is a rare X-linked bleeding disorder caused by a deficiency in factor VIII (FVIII) affecting 1/5,000 males1. Carriers of HA are females carrying the pathogenic variant responsible for the familial HA at a…
- Conditions
- Carrier of Hemophilia A, Desmopressin, Factor VIII Deficiency
- Trial name
- GIDEHAC (NCT06020456)
- Testing
- Desmopressin
- Where
- 12 sites in France
- Volunteers
- 361 people
- Sponsor
- Groupe Maladies hémorragiques de Bretagne
Hypophosphatasia
Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan
This is a multicenter study in Japan. Eleven sites which have already participated in the investigator-initiated clinical study (Early Access Program) will participate in this study.The objective of this study is to gain further…
- Trial name
- NCT02531867
- Testing
- Asfotase Alfa
- Volunteers
- 13 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hemophilia A, Hemophilia B
Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia
Study will look at baseline Vitamin D levels, calcium, albumin, liver enzymes, testosterone, osteocalcin, urine N telopeptides, bone mineral density, nutritional assessment and physical activity assessment of boys with hemophilia…
- Conditions
- Hemophilia A, Hemophilia B, Vitamin D Deficiency
- Trial name
- NCT01090206
- Testing
- Vitamin D and calcium
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Virginia Commonwealth University
HIV-associated Enteropathy
Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
The purpose of the study is to evaluate the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g twice a day (BID) and SBI 5.0 g versus placebo on supporting nutrient…
- Trial name
- NCT01828593
- Testing
- Serum-derived bovine immunoglobulin protein isolate (SBI)
- Where
- 10 sites in United States
- Volunteers
- 103 people
- Sponsor
- Entera Health, Inc
Advanced Breast Cancer, Treatment-Refractory Solid Tumors
TAS-116 Plus Palbociclib in Breast and Rb-null Cancer
The purpose of this study is to evaluate the safety and efficacy of TAS-116 with palbociclib in two groups of patients: Patients with advanced breast cancer that has become worse after taking palbociclib alone Patients with…
- Conditions
- Advanced Breast Cancer, Treatment-Refractory Solid Tumors, Retinoblastoma Deficiency, SCLC
- Trial name
- NCT05655598
- Testing
- Palbociclib Oral Product, TAS-116
- Where
- United States
- Sponsor
- Brown University