AzTrials
AzTrials

Drug-induced Liver InjuryPhase 2/3SILVERNCT05144217

Impact of Silymarin Dosages to Decrease Drug-induced Elevated Liver Enzymes Compared to Placebo

A Phase 2/3 study testing 2x 140 mg per day, 3x 280 mg per day and 1x 1120 mg in people with Drug-induced Liver Injury, run by Prof. Dr. Frank Behrens at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In this clinical study silymarin will be administered in different dosages and compared to placebo in order to address if the liver protecting features of silymarin, measured by changes of liver enzyme concentration, can be improved in patients with drug-induced elevated liver enzymes or drug-induced hepatocellular… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Drug-induced Liver Injury
What is being tested?
2x 140 mg per day, 3x 280 mg per day and 1x 1120 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
19 participants
Where
2 sitesGermany
Study dates
23 Jun 2021to 15 Dec 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Evidence of hepatocellular drug-induced injury due to treatment
  • ALT/AP ratio ≥ 5 ((ALT level/ALT upper limit of normal (ULN))/(AP level/AP ULN)) OR Evidence of drug-induced elevation of liver-enzymes
  • ALT > 40 U/L and ≤ 2 x ULN
  • ALT (> 40 U/L) ≥ 2 weeks and ≤ 3 months 3. Documentation (within the last 4 weeks before screening) of exclusion of liver tissue damage using either ultrasonography of the liver or Fibroscan with results ≤ 7 kPa (fibrosis score of F0 to F1) 4. BMI ≥ 18 and ≤ 30 5. Liver enzyme elevation inducing medication stable for ≥ 8 weeks before screening in the discretion of the treating physician 6. Written informed consent, after having been informed about potential benefit and potential risks of the clinical trial 7. Willing and capable to understand informed consent and follow the protocol

Who cannot join

  • Use of silymarin within the last 6 months
  • Current intake and intake within the last 4 weeks of drugs that have been shown to induce cholestatic or mixed hepatocellular/cholestatic liver injury (inducing cholestatic liver injury: amoxicilline and clavulanic acid, anabolic steroids, chlorpromazine, clopidogrel, erythromycin, irbesartan, mirtazapine, estrogen, terbinafine; inducing mixed liver injury: amitriptyline, azathioprine, captopril, carbamazepine, clindamycin, co-trimoxazole, cyproheptadine, enalapril, flutamide, nitrofurantoin, phenobarbital, phenytoin, sulphonamide, trazodone, verapamil)
  • Patients with chronic liver disease, existing fibrosis or cirrhosis
  • Patients with acute viral hepatitis, autoimmune hepatitis or immune-mediated hepatitis (e.g., with immune checkpoint inhibitor treatment), acute Budd-Chiari syndrome, Wilson disease, and ischemic liver injury
  • Cholestatic or mixed hepatocellular/mixed liver injury
  • Patients with diabetes types 1 or 2
Show all 22Show fewer
  • Any malignancy within the past 5 years
  • Patients with chronic intestinal diseases (e.g., ulcerative colitis) and intestinal barrier dysfunction in the discretion of the treating physician (e.g., patient can be included if disease is judged as stable by the treating physician with no likely interference with the study outcomes and the safety of the patient)
  • Evidence of significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome
  • History of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
  • Known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations, e.g. milk thistle, soy oil, peanut (according to Summary of Product Characteristics (SmPc))
  • Contraindications to use the investigational medicinal product (IMP), e.g. hereditary galactose intolerance, genetic lactase deficiency or glucose-galactose malabsorption (according to SmPC)
  • Subjects with severe or moderate allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
  • Laboratory values other than target parameters out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator
  • Positive anti-HIV-test, antiHBs- or anti-HCV-test at Screening
  • History of or current drug or alcohol dependence
  • Subjects with a positive drug test at screening (incl. alcohol)
  • Regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol for male or ≥ 20 g pure ethanol for female per day
  • Participation in a clinical trial during the last two months prior to individual enrolment of the subject or current participation
  • Use of drugs during the last two weeks prior Baseline that can affect absorption (e.g. laxatives, metoclopramide, loperamide, antacids, H2-receptor antagonists)
  • Subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
  • Subjects who do not agree to apply adequate contraceptive methods as defined in Note for Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (CPMP/ICH/286/95, modification), November 2000

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Universtity Hospital - clinic for dermatology, venerology and allergology

    Frankfurt, Hessia, 60590

  • CIRI

    Frankfurt, Hessia, 60596

Other trials in Germany

About this study

Official title: Impact of Different Silymarin Dosages to Decrease Drug-induced Elevated Liver Enzymes Compared to Placebo in a Prospective Controlled Dose Finding Phase IIb Trial

In this clinical study silymarin will be administered in different dosages and compared to placebo in order to address if the liver protecting features of silymarin, measured by changes of liver enzyme concentration, can be improved in patients with drug-induced elevated liver enzymes or drug-induced hepatocellular liver injury with higher systemic bioavailabilities due to administration of higher oral dosages or administration of higher administration frequency over a 35-day treatment period.

Read the detailed description

In clinical routine care, drug-induced elevation of liver enzymes occurs often in parallel to new treatment initiation, possibly leading to interruption of treatment strategies if liver enzyme elevation does not normalize within 2 to 4 weeks.

Liver injury from medications usually occurs within 6 months of drug initiation and typically within the first 1-4 weeks1. In general, drug-induced liver injury (DILI) is related to the class of drug, the quantity of drug consumed, the patient's age and sex, and such concurrent factors as diabetes mellitus, excessive alcohol intake, e.g. high caloric diet, which can lead to NAFLD/steatosis, or the use of other medications. Drugs administered in higher doses are more likely to cause liver injury, especially drugs that require extensive hepatic metabolism1. Different forms of drug-induced elevation of liver enzymes can be differentiated according to localisation of the injury: hepatocellular or cholestatic liver injury or a mixture of both.Besides methotrexate and isozid, other medications have been reported to induce hepatocellular liver injury: acarbose, allopurinol, amiodarone, baclofen, bupropion, fluoxetine, ketoconazole, lisinopril, losartan, non-steroidal anti-inflammatory drugs (NSAIDs), omeprazole, paracetamol, paroxetine, pyrazinamide, rifampicin, risperidone, sertraline, statins, tetracyclines, trazodone, and valproic acid. Silymarin containing oral preparations are widely used for their liver protecting characteristics. The milk thistle ingredient silibinin is registered for continuous intravenous administration in the case of acute liver intoxications such as consumption of amanita mushrooms. Although its mode of action is still not clear, the clinical therapeutic benefits in patients with liver diseases are documented.

Pharmacokinetics of silymarin after oral administration are well understood. Due to its poor solubility in aqueous media, absorption from the intestinal tract is generally limited. Silymarin's systemic bioavailability of marketed products is therefore rather low, also because of predominant first pass biliary elimination. Exact PK/PD relations of the compound have not been assessed so far.

Hence, in this clinical study silymarin will be administered in different dosages and compared to placebo in order to address the following question: Can liver protecting features of silymarin, measured by changes of liver enzyme concentration, be improved in patients with drug-induced elevated liver enzymes or drug-induced hepatocellular liver injury with higher systemic bioavailabilities due to administration of higher oral dosages or administration of higher administration frequency over a 35-day treatment period?

Being tested
Placebo, 2x 140 mg per day, 3x 280 mg per day, 1x 1120 mg
Keywords
silymarin
Medical subject headings
Chemical and Drug Induced Liver Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    1 capsule per day of placebo

  • 2x 140 mg per dayDrug

    2 capsule per day of silimarit

  • 3x 280 mg per dayDrug

    3 capsule per day of silimarit

  • 1x 1120 mgDrug

    8 capsule per day of silimarit

Study groups in NCT05144217
Study groupRoleWhat they receive
PlaceboPlacebo comparator1 capsule twice per day
Receives: Drug: Placebo
oral administration of 2x 140 mg per dayActive comparator1 capsule twice per day
Receives: Drug: 2x 140 mg per day
oral administration of 3x 280 mg per dayActive comparator2 capsules three times a day
Receives: Drug: 3x 280 mg per day
oral administration of 1x 1120 mg per dayActive comparator8 capsules once per day
Receives: Drug: 1x 1120 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in blood ALT (Alanine-Aminotransferase) in IU/L

    Change in blood ALT in IU/Lin all treatment groups

    Measured: at day 35

Secondary outcomes (116)

  1. Liver enzyme blood parameter AST (Aspartate-Aminotransferase)

    Change of Liver enzyme blood parameter AST in IU/Lin all treatment groups

    Measured: Baseline (prior treatment)

  2. Liver enzyme blood parameter AST

    Change of Liver enzyme blood parameter AST in IU/Lin all treatment groups

    Measured: Day 7

  3. Liver enzyme blood parameter AST

    Change of Liver enzyme blood parameter AST in IU/Lin all treatment groups

    Measured: Day 14

  4. Liver enzyme blood parameters: AST

    Change of Liver enzyme blood parameter AST in IU/Lin all treatment groups

    Measured: Day 21

  5. Liver enzyme blood parameter AST

    Change of Liver enzyme blood parameter AST in IU/Lin all treatment groups

    Measured: Day 28

  6. Change Liver enzyme blood parameter AST

    Change of Liver enzyme blood parameter AST in IU/Lin all treatment groups

    Measured: Day 35

  7. Change Liver enzyme blood parameter ALT

    Change of Liver enzyme blood parameter ALT in IU/Lin all treatment groups

    Measured: Baseline

  8. Change Liver enzyme blood parameter ALT

    Change of Liver enzyme blood parameter ALT in IU/Lin all treatment groups

    Measured: Day 7

  9. Change Liver enzyme blood parameter ALT

    Change of Liver enzyme blood parameter ALT in IU/Lin all treatment groups

    Measured: Day 14

  10. Change Liver enzyme blood parameter ALT

    Change of Liver enzyme blood parameter ALT in IU/Lin all treatment groups

    Measured: Day 21

  11. Change Liver enzyme blood parameter ALT

    Change of Liver enzyme blood parameter ALT in IU/Lin all treatment groups

    Measured: Day 28

  12. Change Liver enzyme blood parameter ALT

    Change of Liver enzyme blood parameter ALT in IU/Lin all treatment groups

    Measured: Day 35

  13. Change Liver enzyme blood parameter GGT (Gamma-Glutamyl-Transferase)

    Change of Liver enzyme blood parameter GGT in IU/Lin all treatment groups

    Measured: Baseline

  14. Change Liver enzyme blood parameter GGT (Gamma-Glutamyl-Transferase)

    Change of Liver enzyme blood parameter GGT in IU/Lin all treatment groups

    Measured: Day 7

  15. Change Liver enzyme blood parameter GGT (Gamma-Glutamyl-Transferase)

    Change of Liver enzyme blood parameter GGT in IU/Lin all treatment groups

    Measured: Day 14

  16. Change Liver enzyme blood parameter GGT (Gamma-Glutamyl-Transferase)

    Change of Liver enzyme blood parameter GGT in IU/Lin all treatment groups

    Measured: Day 21

  17. Change Liver enzyme blood parameter GGT (Gamma-Glutamyl-Transferase)

    Change of Liver enzyme blood parameter GGT in IU/Lin all treatment groups

    Measured: Day 28

  18. Change Liver enzyme blood parameter GGT (Gamma-Glutamyl-Transferase)

    Change of Liver enzyme blood parameter GGT in IU/Lin all treatment groups

    Measured: Day 35

  19. Change Liver enzyme blood parameter AP (Alkaline phosphatase )

    Change of Liver enzyme blood parameter AP in IU/Lin all treatment groups

    Measured: Baseline

  20. Change Liver enzyme blood parameter AP (Alkaline phosphatase )

    Change of Liver enzyme blood parameter AP in IU/Lin all treatment groups

    Measured: Day 7

  21. Change Liver enzyme blood parameter AP (Alkaline phosphatase )

    Change of Liver enzyme blood parameter AP in IU/Lin all treatment groups

    Measured: Day 14

  22. Change Liver enzyme blood parameter AP (Alkaline phosphatase )

    Change of Liver enzyme blood parameter AP in IU/Lin all treatment groups

    Measured: Day 21

  23. Change Liver enzyme blood parameter AP (Alkaline phosphatase )

    Change of Liver enzyme blood parameter AP in IU/L in all treatment groups

    Measured: Day 28

  24. Change Liver enzyme blood parameter AP (Alkaline phosphatase )

    Change of Liver enzyme blood parameter AP in IU/L in all treatment groups

    Measured: Day 35

  25. Change Liver enzyme blood parameter bilirubin

    Change of Liver enzyme blood parameter bilirubin in all treatment groups

    Measured: Baseline

  26. Change Liver enzyme blood parameter bilirubin

    Change of Liver enzyme blood parameter bilirubin in all treatment groups

    Measured: Day 7

  27. Change Liver enzyme blood parameter bilirubin

    Change of Liver enzyme blood parameter bilirubin in all treatment groups

    Measured: Day 14

  28. Change Liver enzyme blood parameter bilirubin

    Change of Liver enzyme blood parameter bilirubin in all treatment groups

    Measured: Day 21

  29. Change Liver enzyme blood parameter bilirubin

    Change of Liver enzyme blood parameter bilirubin in all treatment groups

    Measured: Day 28

  30. Change Liver enzyme blood parameter bilirubin

    Change of Liver enzyme blood parameter bilirubin in all treatment groups

    Measured: Day 35

  31. Change Liver enzyme blood parameter INR (International Normalized Ratio)

    Change of Liver enzyme blood parameter INR in all treatment groups

    Measured: baseline

  32. Change Liver enzyme blood parameter INR (International Normalized Ratio)

    Change of Liver enzyme blood parameter INR in all treatment groups

    Measured: Day 7

  33. Change Liver enzyme blood parameter INR (International Normalized Ratio)

    Change of Liver enzyme blood parameter INR in all treatment groups

    Measured: Day 14

  34. Change Liver enzyme blood parameter INR (International Normalized Ratio)

    Change of Liver enzyme blood parameter INR in all treatment groups

    Measured: Day 21

  35. Change Liver enzyme blood parameter INR (International Normalized Ratio)

    Change of Liver enzyme blood parameter INR in all treatment groups

    Measured: Day 28

  36. Change Liver enzyme blood parameter INR (International Normalized Ratio)

    Change of Liver enzyme blood parameter INR in all treatment groups

    Measured: Day 35

  37. Change Liver enzyme blood parameter Quick value

    Change of Liver enzyme blood parameter Quick value in all treatment groups

    Measured: baseline

  38. Change Liver enzyme blood parameter Quick value

    Change of Liver enzyme blood parameter Quick value in all treatment groups

    Measured: Day 7

  39. Change Liver enzyme blood parameter Quick value

    Change of Liver enzyme blood parameter Quick value in all treatment groups

    Measured: Day 14

  40. Change Liver enzyme blood parameter Quick value

    Change of Liver enzyme blood parameter Quick value in all treatment groups

    Measured: Day 21

  41. Change Liver enzyme blood parameter Quick value

    Change of Liver enzyme blood parameter Quick value in all treatment groups

    Measured: Day 28

  42. Change Liver enzyme blood parameter Quick value

    Change of Liver enzyme blood parameter Quick value in all treatment groups

    Measured: Day 35

  43. Change ALT/AP ratio

    Change of ALT/AP ratio in all treatment groups

    Measured: baseline

  44. Change ALT/AP ratio

    Change of ALT/AP ratio in all treatment groups

    Measured: Day 7

  45. Change ALT/AP ratio

    Change of ALT/AP ratio in all treatment groups

    Measured: Day 14

  46. Change ALT/AP ratio

    Change of ALT/AP ratio in all treatment groups

    Measured: Day 21

  47. Change ALT/AP ratio

    Change of ALT/AP ratio in all treatment groups

    Measured: Day 28

  48. Change ALT/AP ratio

    Change of ALT/AP ratio in all treatment groups

    Measured: Day 35

  49. Lipids analysis

    LDL (Low Density Lipoproteins) in all treatment groups

    Measured: Baseline

  50. Lipids analysis LDL

    LDL (Low Density Lipoproteins) in all treatment groups

    Measured: Day 7

  51. Lipids analysis LDL

    LDL (Low Density Lipoproteins) in all treatment groups

    Measured: Day 14

  52. Lipids analysis LDL

    LDL (Low Density Lipoproteins) in all treatment groups

    Measured: Day 21

  53. Lipids analysis LDL

    LDL (Low Density Lipoproteins) in all treatment groups

    Measured: Day 28

  54. Lipids analysis LDL

    LDL (Low Density Lipoproteins) in all treatment groups

    Measured: Day 35

  55. Lipids analysis

    HDL (High Density Lipoproteins) in all treatment groups

    Measured: baseline

  56. Lipids analysis

    HDL (High Density Lipoproteins) in all treatment groups

    Measured: Day 7

  57. Lipids analysis

    HDL (High Density Lipoproteins) in all treatment groups

    Measured: Day 14

  58. Lipids analysis

    HDL (High Density Lipoproteins) in all treatment groups

    Measured: Day 21

  59. Lipids analysis

    HDL (High Density Lipoproteins) in all treatment groups

    Measured: Day 28

  60. Lipids analysis

    HDL (High Density Lipoproteins) in all treatment groups

    Measured: Day 35

  61. Lipids analysis

    VLDL (very low Density Lipoproteins) in all treatment groups

    Measured: Day baseline

  62. Lipids analysis VLDL

    VLDL (very low Density Lipoproteins) in all treatment groups

    Measured: Day 7

  63. Lipids analysis VLDL

    VLDL (very low Density Lipoproteins) in all treatment groups

    Measured: Day 14

  64. Lipids analysis VLDL

    VLDL (very low Density Lipoproteins) in all treatment groups

    Measured: Day 21

  65. Lipids analysis VLDL

    VLDL (very low Density Lipoproteins) in all treatment groups

    Measured: Day 28

  66. Lipids analysis VLDL

    VLDL (very low Density Lipoproteins) in all treatment groups

    Measured: Day 35

  67. Lipids analysis triglycerides

    triglycerides in all treatment groups

    Measured: baseline

  68. Lipids analysis triglycerides

    triglycerides in all treatment groups

    Measured: Day 7

  69. Lipids analysis triglycerides

    triglycerides in all treatment groups

    Measured: Day 14

  70. Lipids analysis triglycerides

    triglycerides in all treatment groups

    Measured: Day 21

  71. Lipids analysis triglycerides

    triglycerides in all treatment groups

    Measured: Day 28

  72. Lipids analysis triglycerides

    triglycerides in all treatment groups

    Measured: Day 35

  73. Lipids analysis total cholesterol

    total cholesterol in all treatment groups

    Measured: baseline

  74. Lipids analysis total cholesterol

    total cholesterol in all treatment groups

    Measured: Day 7

  75. Lipids analysis total cholesterol

    total cholesterol in all treatment groups

    Measured: Day 14

  76. Lipids analysis total cholesterol

    total cholesterol in all treatment groups

    Measured: Day 21

  77. Lipids analysis total cholesterol

    total cholesterol in all treatment groups

    Measured: Day 28

  78. Lipids analysis total cholesterol

    total cholesterol in all treatment groups

    Measured: Day 35

  79. bloodparameter assessment

    fasting glucose value in all treatment groups

    Measured: baseline

  80. bloodparameter assessment

    fasting glucose value in all treatment groups

    Measured: Day 7

  81. blood parameter assessment

    fasting glucose value in all treatment groups

    Measured: Day 14

  82. blood parameter assessment

    fasting glucose value in all treatment groups

    Measured: Day 21

  83. blood parameter assessment

    fasting glucose value in all treatment groups

    Measured: Day 28

  84. blood parameter assessment

    fasting glucose value in all treatment groups

    Measured: Day 35

  85. Proportion of patients with normalization in liver enzyme blood parameters

    normalisation of liver enzyme blood parameters such as AST (< 40 IU/L), ALT (< 40 IU/L), GGT, AP, bilirubin, INR, Quick

    Measured: Day 35

  86. Plasma silymarin dose concentration

    concentration of silymarin

    Measured: Base line

  87. Plasma silymarin dose concentration

    concentration of silymarin

    Measured: day 7

  88. Plasma silymarin dose concentration

    concentration of silymarin

    Measured: day 14

  89. Plasma silymarin dose concentration

    concentration of silymarin

    Measured: day 21

  90. Plasma silymarin dose concentration

    concentration of silymarin

    Measured: day 28

  91. Plasma silymarin dose concentration

    concentration of silymarin

    Measured: day 35

  92. Fibroscan value

    measurement of Fibroscan

    Measured: baseline

  93. Fibroscan value

    measurement of Fibroscan

    Measured: day 14

  94. Fibroscan value

    measurement of Fibroscan

    Measured: day 35

  95. Fibrosis score

    score F0 to F4

    Measured: baseline

  96. Fibrosis score

    score F0 to F4

    Measured: Day 14

  97. Fibrosis score

    score F0 to F4

    Measured: Day 35

  98. CAP score

    score measured in dB/m

    Measured: baseline

  99. CAP score

    score measured in dB/m

    Measured: day 14

  100. CAP score

    score measured in dB/m

    Measured: day 35

  101. Body Mass Index (BMI)

    index measured in weight and height

    Measured: baseline

  102. Silymarin concentration in blood plasma in pharmakokinetic substudy - AUC

    assessement of area under the curve (AUC),

    Measured: baseline

  103. Silymarin concentration in blood plasma in pharmakokinetic substudy - tmax

    assessement of time to maximal concentration (tmax)

    Measured: baseline

  104. Silymarin concentration in blood plasma in pharmakokinetic substudy - Cmax

    assessement of maximal concentration (Cmax)

    Measured: baseline

  105. Treatment adherence

    measured by patient diary

    Measured: Baseline

  106. Treatment adherence

    measured by patient diary

    Measured: Day 7

  107. Treatment adherence

    measured by patient diary

    Measured: Day 14

  108. Treatment adherence

    measured by patient diary

    Measured: Day 21

  109. Treatment adherence

    measured by patient diary

    Measured: Day 28

  110. Treatment adherence

    measured by patient diary

    Measured: Day 35

  111. quality of life measurements

    measured by short form survey (SF36) questionnaire

    Measured: baseline

  112. quality of life measurements

    measured by short form survey (SF36) questionnaire

    Measured: Day 7

  113. quality of life measurements

    measured by short form survey (SF36) questionnaire

    Measured: Day 14

  114. quality of life measurements

    measured by short form survey (SF36) questionnaire

    Measured: Day 21

  115. quality of life measurements

    measured by short form survey (SF36) questionnaire

    Measured: Day 28

  116. quality of life measurements

    measured by short form survey (SF36) questionnaire

    Measured: Day 35

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2021
  2. Study start23 Jun 2021
  3. Primary completion12 Dec 2024
  4. Study completion15 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective placebo-controlled dose-finding study
Masking
Single blind
Who is masked
Participant
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05144217
Sponsor's protocol ID
TMP-2501-2019-2
Acronym
SILVER
Status last verified
Jan 2026
First submitted
21 Nov 2021
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing 2x 140 mg per day, 3x 280 mg per day and 1x 1120 mg in people with Drug-induced Liver Injury, run by Prof. Dr. Frank Behrens at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in blood ALT (Alanine-Aminotransferase) in IU/L (time frame: at day 35). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05144217.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in