Clinical trials: De-escalation
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Kidney Transplantation
A Dose Escalation Study in de Novo Renal Transplantation
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
- Trial name
- NCT04311632
- Testing
- TCD601, Tacrolimus (TAC), Corticosteroids (CS)
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- ITB-Med LLC
Ulcerative Colitis
A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
Participants who were in clinical remission on 200 milligram (mg) filgotinib once daily for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), were planned to be rolled over…
- Trial name
- CAPYBARA (NCT05479058)
- Testing
- Filgotinib
- Where
- 50 sites in United States, Belgium and 11 more
- Volunteers
- 22 people
- Sponsor
- Lakefront Biotherapeutics NV
Unresectable Stage IIIB-IV Malignant Melanoma
Study to Evaluate the Safety/ Efficacy of T-VEC in Japanese Subjects With Unresectable Stage IIIB-IV Malignant Melanoma
There are 2 fold of purposes for this study. 1 is to evaluate safety and tolerability and the other is to study the anti-tumor effects of talimogene laherparepvec in Japanese participants with unresectable stage IIIB-IV malignant…
- Trial name
- NCT03064763
- Testing
- Talimogene laherparepvec
- Where
- 9 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Amgen
Typhoid Fever
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is highly endemic and an efficacious vaccine…
- Trial name
- NCT01229176
- Testing
- Vi-CRM197 vaccine, Vi Polysaccharide (PS) vaccine, Pneumococcal conjugate vaccine
- Where
- 2 sites in India, Pakistan
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Novartis
SARS-CoV-2
A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age
The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children as intramuscular (IM) injection in 2 doses (in Parts 1 and 2) and 3 doses (in Part 3), and a third dose or an…
- Trial name
- NCT04796896
- Testing
- mRNA-1273, mRNA-1273.214
- Where
- 91 sites in United States, Canada
- Volunteers
- 11,942 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Advanced Non CNS Tumors
Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors
This is a phase 1 study to evaluate the safety of intralesional talimogene laherparepvec administration in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection
- Trial name
- NCT02756845
- Testing
- Talimogene Laherparepvec
- Where
- 22 sites in United States, Belgium and 5 more
- Volunteers
- 15 people
- Sponsor
- Amgen
Acute Coronary Syndrome
MT1002 Phase II Study in ACS Patients With PCI
This is an open-label, sequential-dose escalation/de-escalation trial testing 3 dose levels of MT1002 in patients undergoing PCI due to ACS with NSTEMI.
- Trial name
- NCT04723186
- Testing
- MT1002 for Injection
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Kidney Transplantation
A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
- Trial name
- NCT06365437
- Testing
- TCD601, Tacrolimus (TAC), Corticosteroids (CS)
- Where
- 7 sites in Austria, Spain and 1 more
- Volunteers
- 33 people
- Sponsor
- ITB-Med LLC