A Phase 1/2 interventional study of recombinant human erythropoietin(rhEPO) in Amyotrophic Lateral Sclerosis, sponsored by Hanyang University Seoul Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-02-08.
Sponsored by Hanyang University Seoul Hospital · Phase 1/2, Interventional, and Other
Among 21 studies in Amyotrophic Lateral Sclerosis with a site in Korea, Republic of — 3 open to participants now, 6 under way, 2 of them phase 3. Amyotrophic Lateral Sclerosis · Korea, Republic of.
Among the 21 studies in Amyotrophic Lateral Sclerosis with a site in Korea, Republic of, this one is the 9th largest by planned enrollment of the 19 interventional ones that give a count, is one of 2 that started in 2016, is one of 4 in phase 1/2, and was the 7th registered.
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
Browse Amyotrophic Lateral Sclerosis studies →3 of the 21 studies in Amyotrophic Lateral Sclerosis with a site in Korea, Republic of are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in Korea, Republic of, Australia, Belgium and 6 more countries
1ST Biotherapeutics, Inc. · Sites in Korea, Republic of
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 192 Amyotrophic Lateral Sclerosis studies recruiting now, 117 (61%) set no upper age limit and 23 (12%) stop at 75 or younger; 15 take children under 18; 55 take healthy volunteers.
This study: 25 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 9 · Phase 3 4
First in 2011; this study’s year is marked. 2 started in 2016.
This study's planned enrollment of 64 is above the median of 38 across 662 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Median enrollment 64 across the 19 interventional studies, 40 across the 2 observational. Of the 14 that completed or were terminated, 7 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
14 of 21 have an industry lead sponsor. The 10 most frequent:
Hanyang University Seoul Hospital is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
Hanyang University Seoul Hospital has 3 studies filed under Amyotrophic Lateral Sclerosis — fewer than ten, so there is no comparison to draw.
1 of the studies in Amyotrophic Lateral Sclerosis with a site in Korea, Republic of that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04856982Phase 3BiogenStudy to Learn If Tofersen (BIIB067) Can Delay ALS Symptoms and About Its Safety in Adults With a SOD1 Gene Mutation Who Have Not Yet Developed ALS Symptoms | 2027-08-07 |
Among the 21 studies in Amyotrophic Lateral Sclerosis with a site in Korea, Republic of, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Erythropoietin is neuroprotective in animal models of neurodegenerative diseases including amyotrophic lateral sclerosis (ALS). The aim of this study was to determine the safety and feasibility of repetitive high-dose recombinant human erythropoietin (rhEPO) therapy in ALS patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Inject Normal saline 100ml \* 12 times (1month apart)
Drug: recombinant human erythropoietin(rhEPO)
Inject 500IU/kg of EPO mixed with normal saline 100ml \* 12 times (1month apart)
Drug: recombinant human erythropoietin(rhEPO)
Inject 750IU/kg of EPO mixed with normal saline 100ml \* 12 times (1month apart)
Drug: recombinant human erythropoietin(rhEPO)
Injection of erythropoietin every months (total 12 months)
changes of ALSFRS-R score
changes between score of ALSFRS-R at initial and study end point
Time frame: Last visit [15th visit (15 months)]
Plan to share: Undecided
Started Jun 2016 (actual). Primary completion is estimated for Dec 2020, 54 months after the start.
Of 36 phase 1/2 interventional studies under Amyotrophic Lateral Sclerosis, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 57. This study's planned 54 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Amyotrophic Lateral Sclerosis →
Hanyang University Seoul Hospital