A Phase 2 interventional study of 1000mg DS102 (BID) in Severe Acute Decompensated Alcoholic Hepatitis, sponsored by Afimmune. Terminated at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-29.
Sponsored by Afimmune · Phase 2, Interventional, and Treatment
Among 38 studies in Hepatitis, Alcoholic with a site in United States — 7 open to participants now, 7 under way, 1 of them phase 3. Hepatitis, Alcoholic · United States.
Among the 38 studies in Hepatitis, Alcoholic with a site in United States, this one is the 23rd largest by enrollment of the 28 interventional ones that give a count, is one of 2 that started in 2018, is one of 17 in phase 2, and was the 22nd registered.
114 studies on the registry are indexed under Hepatitis, Alcoholic; 25 are open to participants now.
Browse Hepatitis, Alcoholic studies →7 of the 38 studies in Hepatitis, Alcoholic with a site in United States are open now. Recruiting first, the newest first:
Bausch Health Americas, Inc. · Sites in United States
Ages 18+
HepQuant, LLC · Sites in United States
Ages 18+
Prasun Kumar Jalal · Sites in United States
Ages 18–75
The Cleveland Clinic · Sites in United States
Ages 21–65
Johns Hopkins University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 17 Hepatitis, Alcoholic studies recruiting now, 9 (53%) set no upper age limit and 8 (47%) stop at 75 or younger; none take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · 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.
38 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 4 · Phase 2 20 · Phase 3 5
First in 2006; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 9 is below the median of 60 across 81 interventional studies indexed under Hepatitis, Alcoholic.
Median enrollment 44 across the 28 interventional studies, 327 across the 10 observational. Of the 28 that completed or were terminated, 17 (61%) have results posted.
This tab as a report to print or save as PDF → With an account.
15 of 38 have an industry lead sponsor. The 10 most frequent:
Afimmune is the lead sponsor of 5 studies on the registry; none are open to participants now.
Afimmune has 1 study filed under Hepatitis, Alcoholic — fewer than ten, so there is no comparison to draw.
2 of the studies in Hepatitis, Alcoholic with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07428538Phase 3Bausch Health Americas, Inc.Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH) | 2027-11 |
| NCT03845205Johns Hopkins UniversityAlcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for SAH | 2027-06 |
Add all 2 to your calendar (.ics) → With an account.
Among the 38 studies in Hepatitis, Alcoholic with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this randomised, double-blind, placebo-controlled, phase II study is to assess the efficacy and safety of orally administered DS102 in adult patients with acute decompensated alcoholic hepatitis
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.
Female patients, or female partners of male patients, of child bearing potential must use highly effective methods or have a sterilised partner for the duration of the study. Highly effective birth control methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include intrauterine device or sexual abstinence.
Note: A woman is considered of child bearing potential (), i.e. fertile, following menarche and until becoming unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy Note: Hormonal contraceptives are in patients with severe hepatic diseases and are not acceptable as a birth control method in this study Note: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject
Exclusion Criteria:
Other causes of liver disease including:
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 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.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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).
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to the open label pilot phase received 1000mg DS102 (BID)for 28 days.
Drug: 1000mg DS102 (BID)
Participants assigned to the open label pilot phase received 1000mg DS102 (BID)for 28 days.
Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and SUSARs.
To evaluate the safety of orally administered DS102 in the treatment of adult patients with severe acute decompensated AH.
Time frame: Up to 28 days.
Descriptive Statistics for Plasma Total 15(S)-HEPE and Unesterified 15(S)-HEPE Pharmacokinetic Results for 1000 mg BD DS102 Administered Orally Twice-daily to Patients With Alcoholic Hepatitis
Descriptive Statistics for Plasma Total 15(S)-HEPE and Unesterified 15(S)-HEPE Pharmacokinetic Results for 1000 mg BD DS102 Administered Orally Twice-daily to Patients with Alcoholic Hepatitis.
Time frame: Up to 7 days
This was a multicentre, double blind, placebo controlled, 2-arm parallel group comparison (Phase 2) study, preceded by an open label pilot phase, in which six patients were to receive open label treatment with 2000mg DS102 (1000mg BID) within 30 minutes after a meal for 28 days.
| Milestone | 1000mg DS102 (BID) |
|---|---|
| Started | 9 |
| Completed | 5 |
| Not completed | 4 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Other sae and ae | 2 |
To evaluate the safety of orally administered DS102 in the treatment of adult patients with severe acute decompensated AH.
| Number of Events | 1000mg DS102 (BID) |
|---|---|
| Total Number of TEAEs | 7 |
| Total Number of Serious TEAEs | 4 |
| Total Number of Serious Treatment Related TEAEs | 1 |
| Total Number of Treatment Related TEAEs | 1 |
| Total Number of Not Treatment Related TEAEs | 6 |
Descriptive Statistics for Plasma Total 15(S)-HEPE and Unesterified 15(S)-HEPE Pharmacokinetic Results for 1000 mg BD DS102 Administered Orally Twice-daily to Patients with Alcoholic Hepatitis.
| ng/mL | 1000mg DS102 (BID) |
|---|---|
| Day 0 Unesterified 15(S)-HEPE | 542 ± 399.4 |
| Day 7 Unesterified 15(S)-HEPE | 1060 ± 1073 |
| Day 0 Total 15(S)-HEPE | 3110 ± 3721 |
| Day 7 Total 15(S)-HEPE | 4470 ± 3601 |
Collected over Up to 90 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1000mg DS102 (BID) | 2/9 (22.2%) | 4/9 (44.4%) | 7/9 (77.8%) |
| Event | 1000mg DS102 (BID) |
|---|---|
| Cardiac ArrestCardiac disorders | 1/9 |
| Septic ShockInfections and infestations | 1/9 |
| Metabolic encephalopathyNervous system disorders | 1/9 |
| Multiple organ dysfunction syndromeGeneral disorders | 1/9 |
| Mental status changePsychiatric disorders | 1/9 |
| Renal FailureRenal and urinary disorders | 1/9 |
| Pulmonary OedemaRespiratory, thoracic and mediastinal disorders | 1/9 |
| Hypovolaemic ShockVascular disorders | 1/9 |
| Event | 1000mg DS102 (BID) |
|---|---|
| Abdominal distensionGastrointestinal disorders | 2/9 |
| Aspartate Aminotransferase increasedInvestigations | 2/9 |
| FallInjury, poisoning and procedural complications | 2/9 |
| Abdominal PainGastrointestinal disorders | 1/9 |
| DiarrhoeaGastrointestinal disorders | 1/9 |
| FlatulenceGastrointestinal disorders | 1/9 |
| GlossitisGastrointestinal disorders | 1/9 |
| VomitingGastrointestinal disorders | 1/9 |
| AstheniaGeneral disorders | 1/9 |
| Localised OedemaGeneral disorders | 1/9 |
The Full Analysis Set (FAS) included all patients who received at least one dose of investigational product. Patients were analysed according to the treatment they were assigned to, irrespective of what treatment they actually received.
| Age, Continuous(years) | 1000mg DS102 (BID) |
|---|---|
| Mean | 53.2 ± 12.94 |
| Sex: Female, Male(Participants) | 1000mg DS102 (BID) |
|---|---|
| Female | 3 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | 1000mg DS102 (BID) |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | 1000mg DS102 (BID) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2018 to primary completion in Jun 2019, 6 months.
Results were first posted in Jul 2022, 3 years 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Afimmune