Clinical trials: Biologic
Pelvic Organ Prolapse
Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates
This study is to determine whether the use of a composite biologic/synthetic graft during abdominal sacrocolpopexy leads to a lower rate of erosion while maintaining durability.
- Trial name
- NCT00581412
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of California, Irvine
Diphtheria, Tetanus
A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine
This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of age).
- Conditions
- Diphtheria, Tetanus, Acellular Pertussis
- Trial name
- NCT00109330
- Testing
- Combined diphtheria, tetanus, acellular pertussis vaccine
- Where
- 44 sites in United States
- Volunteers
- 4,116 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA
The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA.
- Trial name
- NCT00334607
- Testing
- 2-dose oral live attenuated G1P[8] human rotavirus vaccine
- Where
- 42 sites in United States
- Volunteers
- 484 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Shock, Septic
Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients With Septic Shock
A prognostic score was proposed by the investigative team to predict death at 1 month. This score is based on certain biological markers, scored under emergency conditions in the first 24 hours of routine clinical practice…
- Trial name
- SEPSICOAG (NCT01231672)
- Testing
- Routine biological analyses
- Where
- 7 sites in France
- Volunteers
- 780 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Influenza
Post-Authorization Safety Study of GSK Biologicals' Pandemic Influenza Vaccine (H1N1) in the United Kingdom
The focus of this study is to assess the safety of GSK's H1N1 vaccine in real life conditions as soon as the vaccine is used, in a mass vaccination programme, and with a system for rapid generation, communication and evaluation…
- Trial name
- H1N1 PASS UK (NCT00996853)
- Testing
- Safety follow up
- Where
- 91 sites in United Kingdom
- Volunteers
- 9,206 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rheumatoid Arthritis, Hepatitis B Reactivation
Entecavir for Biological Agents Associated HBV Reactivation in Inflammatory Arthritis Patients
Antiviral prophylaxis can prevent the risk of biologic agents-associated HBV reactivation in hepatitis B inactive carriers and patients with past HBV infection
- Conditions
- Rheumatoid Arthritis, Hepatitis B Reactivation, Exposure to Hepatitis B Virus
- Trial name
- NCT01907230
- Testing
- Entecavir
- Where
- Taiwan
- Volunteers
- 115 people
- Sponsor
- Taipei Veterans General Hospital, Taiwan
Idiopathic Pulmonary Fibrosis
JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF
A phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for Injection in subjects with IPF.
- Trial name
- NCT03538301
- Testing
- ND-L02-s0201 (Low Dose), ND-L02-s0201 (High Dose)
- Where
- 33 sites in United States, Germany and 2 more
- Volunteers
- 123 people
- Sponsor
- Nitto Denko Corporation
Rheumatoid Arthritis
A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active Rheumatoid Arthritis
This multicenter, open-label study will evaluate the efficacy and safety of subcutaneously administered RoActemra/Actemra (tocilizumab) as monotherapy or in combination with methotrexate or other non-biologic DMARDs in patients…
- Trial name
- NCT01995201
- Testing
- DMARD, methotrexate, tocilizumab [RoActemra/Actemra]
- Where
- 53 sites in Ireland, Portugal and 1 more
- Volunteers
- 401 people
- Sponsor
- Hoffmann-La Roche
Cerebrovascular Disease
Creation of a Biological Collection for Medical Research Purposes for Patients at the Reference Center for Rare Diseases of the Blood Vessels of the Brain and Eye at Lariboisière Hospital
The aim of establishing a biological collection associated with the existing rare cerebral vascular disease cohort is to identify new prognostic or disease progression biomarkers that could improve patient care or identify new…
- Trial name
- B-MRVC (NCT07264972)
- Testing
- additional samples for research purposes
- Where
- France
- Volunteers
- 500 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Herpes Simplex Type 2
Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
The purpose of this study is to evaluate the effect of recombinant human heat shock protein 70-polyvalent peptide complex (HerpV) vaccine administration on recurring episodes of genital herpes by evaluating viral shedding before…
- Trial name
- NCT01687595
- Testing
- HerpV and QS-21
- Where
- 5 sites in United States
- Volunteers
- 80 people
- Sponsor
- Agenus Inc.
Biological Availability
Drug-drug Interaction Between Rifampicin and Progestins/Ethinylestradiol and Midazolam
Quantify the effect of a probe CYP3A4 inducer (Rifampicin) on the pharmacokinetics of levonorgestrel, norethindrone, desogestrel, dienogest, drospirenone,estradiol and midazolam
- Trial name
- NCT03353857
- Testing
- levonorgestrel/ Microlut, Norethindrone/ Noriday, Desogestrel/ Cerazette
- Where
- 2 sites in Germany
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Bayer
Asthma
Craving to Biologics Used in Severe Asthma
Some patients treated with biologics for severe asthma experience a craving to the next biological administration. This phenomenon has never been described before.
- Trial name
- CROCUS (NCT05426538)
- Where
- Netherlands
- Volunteers
- 150 people
- Sponsor
- Frisius Medisch Centrum
Glioblastoma, Malignant Glioma
Treatment Response and Prognosis in Glioma Patients: Q Cell and Its Biological Characteristics
The purpose of this study is to determine whether Q cells separated from the glioma sample are determinants in treatment response and prognosis of glioma patients
- Trial name
- NCT02047058
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Meningococcal Infection
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers
This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.
- Trial name
- NCT01340898
- Testing
- Meningococcal vaccine GSK 134612, SynflorixTM, Infanrix-IPV/HiberixTM
- Where
- 2 sites in Lebanon, Mexico
- Volunteers
- 753 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Telomere Biology Disorders With Bone Marrow Failure
Rollover Study From EXG-US-01
This is a long-term rollover follow-up study for Phase I/II study (Protocol EXG-US-01).
- Trial name
- NCT05868499
- Testing
- EXG34217
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Elixirgen Therapeutics, Inc.
HPV Infection
Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating HPV
Conducting an early phase clinical trial to assess HPV Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of HPV patients. 1.
- Trial name
- 9vHPV-BCG (NCT06959563)
- Testing
- 9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Hepatitis B
A Study of the Immune Response to Heplisav in Healthy Older Adults
This study will investigate the response of the immune system to a hepatitis B (HB) vaccine in healthy adults 50 to 70 years of age. This study is partially funded by the National Institute of Allergy and Infectious Diseases.
- Trial name
- NCT01999699
- Testing
- HEPLISAV
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Biological Availability
Stable Isotope Method to Assess Dietary Protein Quality
The evaluation of protein quality has been identified as the top priority question by the Food and Agricultural Organization (FAO) of the United Nations.
- Trial name
- NCT02966704
- Testing
- intrinsically labeled milk protein
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Wageningen University
Malignant Glioma, Glioblastoma Multiforme
Safety and Dose-Finding Study of TM-601 in Adults With Recurrent Malignant Glioma
The purpose of this study is to evaluate the safety and biologically active dose of TM-601 in adult patients with recurrent malignant glioma.
- Conditions
- Malignant Glioma, Glioblastoma Multiforme, GBM, Astrocytoma
- Trial name
- NCT00591058
- Testing
- TM-601
- Where
- 7 sites in United States
- Volunteers
- 36 people
- Sponsor
- TransMolecular
Fibromyalgia
QOL Efficacy of Adapted Physical Activity for Patients With Fibromyalgia
Fibromyalgia affects at least 4% of the population. This chronic painful pathology is a source of social exclusion with a major impact on professional activity; To our knowledge, no study has demonstrated with sufficient evidence…
- Trial name
- NCT03640806
- Testing
- PHYSICAL ACTIVITY
- Where
- France
- Volunteers
- 80 people
- Sponsor
- Assistance Publique Hopitaux De Marseille