Clinical trials: Long Term Follow-up
Hemorrhagic Fever, Ebola
Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3 clinical studies.
- Trial name
- NCT02661464
- Testing
- Ad26.ZEBOV, MVA-BN-Filo
- Where
- 16 sites in United States, Burkina Faso and 5 more
- Volunteers
- 677 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Tetanus, Poliomyelitis
Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™
The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.
- Conditions
- Tetanus, Poliomyelitis, Haemophilus Influenzae Type b, Acellular Pertussis
- Trial name
- NCT01358825
- Testing
- Blood Sampling
- Where
- 4 sites in Norway, Sweden
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the GSK Biologicals' 580299 HPV…
- Trial name
- NCT00947115
- Testing
- Blood sampling, Cervico-vaginal secretion (CVS) samples
- Where
- 6 sites in Germany, Poland
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Herpes Zoster
Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine at 9 and 10 Years After Vaccine Administration and Assessment of Re-vaccination With 2 Additional Doses at 10 Years After Initial Vaccination, in Healthy Subjects Aged 60 Years of Age(YOA) and Older
The purpose of this study is to evaluate the persistence of immune response to the HZ vaccine as well as safety up to 10 years after the first dose of initial vaccination course.
- Trial name
- NCT02735915
- Testing
- Herpes Zoster Vaccine GSK1437173A
- Where
- 7 sites in Czechia, Germany and 1 more
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pulmonary Arterial Hypertension
An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study.
- Trial name
- NCT01560637
- Testing
- UT-15C (treprostinil diolamine)
- Where
- 153 sites in United States, Argentina and 21 more
- Volunteers
- 471 people
- Sponsor
- United Therapeutics
Aortic Valve Stenosis
5 Year Observation of Patients With PORTICO Valves
The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.
- Trial name
- PORTICO-1 (NCT01802788)
- Testing
- St Jude Medical Portico replacement aortic valve, Transcatheter Aortic Valve Implant
- Where
- 60 sites in Australia, Belgium and 11 more
- Volunteers
- 1,032 people
- Sponsor
- Abbott Medical Devices
Hepatitis B, Hepatitis A
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule
The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a 3 dose vaccination schedule of combined hepatitis…
- Trial name
- NCT00289718
- Testing
- Twinrix™ adult
- Where
- Belgium
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Trifecta™ Long Term Follow-Up (LTFU) Study
The Trifecta™ LTFU Study is a single-arm, multi-center, prospective, non-randomized, post-market study conducted in the United States and Canada to collect long-term safety and effectiveness data through 10 years after implant of…
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT01593917
- Testing
- Trifecta™ Valve
- Where
- 11 sites in United States, Canada
- Volunteers
- 329 people
- Sponsor
- Abbott Medical Devices
Cystinosis
Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103)
Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate immediate release) which must be taken every…
- Trial name
- NCT01197378
- Testing
- Cysteamine Bitartrate Delayed-release Capsules
- Where
- 10 sites in United States, France and 1 more
- Volunteers
- 60 people
- Sponsor
- Amgen
Growth and Development
Long-term Monitoring of Growth and Development of Pediatric Patients Previously Treated With Everolimus
The primary objective of CRAD001M2305 was to report the long-term effects of everolimus treatment on height, weight and sexual development (using Tanner Stages) in children and adolescents with Tuberous Sclerosis Complex…
- Trial name
- EXIST-LT (NCT02338609)
- Testing
- Everolimus
- Where
- 6 sites in United States, Belgium and 1 more
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
Hyponatremia
An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia
The objective of this trial was to provide 6 months of safety follow-up for children and adolescents with dilutional (euvolemic or hypervolemic) hyponatremia who had previously participated in a tolvaptan hyponatremia trial and…
- Trial name
- NCT02020278
- Testing
- Tolvaptan
- Where
- 23 sites in United States, Belgium and 6 more
- Volunteers
- 3 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Epilepsies, Partial
A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures
This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in long-term administration in patients who completed N01020 [NCT00160165] or N01221 [NCT00280696].
- Trial name
- NCT00367432
- Testing
- Levetiracetam
- Where
- 53 sites in Japan
- Volunteers
- 398 people
- Sponsor
- UCB Japan Co. Ltd.
Fabry Disease, Lysosomal Storage Diseases
A Long Term Follow-Up Study of Fabry Disease Subjects Treated With FLT190
Fabry disease is a rare, X-linked inborn error of glycosphingolipid metabolism caused by an abnormal gene encoding the α-galactosidase A (αGLA) enzyme.
- Trial name
- NCT04455230
- Testing
- FLT190
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 3 people
- Sponsor
- Spur Therapeutics
Kidney Transplant Failure and Rejection
A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation
The rationale for the current protocol is to collect data from extended follow up in subjects that have received a kidney transplant following imlifidase dosing to provide a better understanding regarding the long-term outcome…
- Trial name
- NCT03611621
- Testing
- Imlifidase
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 31 people
- Sponsor
- Hansa Biopharma AB
Infections, Cytomegalovirus
Evaluation of the Long-term Persistence of GlaxoSmithKline (GSK) Biologicals' Candidate Cytomegalovirus (CMV) Vaccine
The purpose of this study is to evaluate the persistence of the vaccine induced immune responses at Month 48 (Year 4) and Month 60 (Year 5) in healthy subjects who received 3 doses of GSK Biologicals' candidate CMV vaccine…
- Trial name
- NCT01357915
- Testing
- Blood sampling, GSK149203A
- Where
- 2 sites in Belgium
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Leber Hereditary Optic Neuropathy
RESCUE and REVERSE Long-term Follow-up
The goal of this clinical trial is to assess the long-term safety and efficacy of GS010, a gene therapy, and assess the quality of life in subjects with LHON due to the G11778A ND4 mitochondrial mutation and who were treated in…
- Trial name
- RESTORE (NCT03406104)
- Testing
- GS010
- Where
- 7 sites in United States, France and 3 more
- Volunteers
- 62 people
- Sponsor
- GenSight Biologics
Pulmonary Fibrosis
Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174)
Primary objective of this study is to investigate the long-term tolerability and safety profile of BIBF 1120 on top of pirfenidone treatment in patients with Idiopathic Pulmonary Fibrosis who have completed a prior clinical trial…
- Trial name
- NCT01417156
- Testing
- Nintedanib, Pirfenidoneone
- Where
- 4 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Boehringer Ingelheim
Hepatitis B
Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)
This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™.
- Trial name
- NCT00240539
- Testing
- Blood sampling
- Where
- Thailand
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Encephalitis, Japanese Encephalitis
Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers
This is a long-term follow-up of the persistence of immune response in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644) .
- Trial name
- NCT01001988
- Testing
- Blood sample, JE-CV administered in Study JEC02
- Where
- 4 sites in Philippines, Thailand
- Volunteers
- 596 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Short Children Born Small for Gestational Age (SGA)
Long-term Safety Follow-up After Growth Hormone Treatment of Short Children Born Small for Gestational Age
This study is performed as part of the Marketing Authorisation Holder's post-marketing pharmacovigilance plan to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in…
- Trial name
- SGA (NCT01491854)
- Testing
- Bloodsampling
- Where
- 23 sites in Czechia, Georgia and 4 more
- Volunteers
- 130 people
- Sponsor
- Sandoz