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Could growth factors help repair the liver in cirrhosis?

NCT ID NCT07002827

Disease control Sponsor: Institute of Liver and Biliary Sciences, India Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether giving a combination of two growth factors (G-CSF and darbepoetin) in single or repeated cycles can improve immune function in people with early decompensated cirrhosis. Sixty participants will be randomly assigned to receive either the growth factor combination or standard medical care. The main goal is to see changes in immune cell activity over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Granulocyte colony stimulating factor (G-CSF) and darbepoetin
What this could lead to
If successful, this could point toward a new way to boost the immune system and slow liver disease progression in people with early decompensated cirrhosis.
What could go wrong
This is a small pilot study with only 60 participants, so results may not apply to everyone. The treatment involves growth factors, which can cause side effects like bone pain or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-70 years 2. Decompensated cirrhosis patients 3. Uncomplicated ascites, 4. CTP ≤ 9B and MELD \<16 5. BM Hematopoietic stem cell reserve \> 0.4 6. Given informed consent Exclusion Criteria: 1. Patients with age less than 18 years or more than 65 years 2. Lack of informed consent 3. Patients with a history of serious allergic reactions to the active component, filgrastim, other human granulocyte colony-stimulating factors, or any of the ingredients 4. Evidence of alcoholic hepatitis/active alcohol abuse last intake ≤ 3 months 5. Suspected autoimmune hepatitis (ANA/ASMA-positive in titers 1:80 and/ or IgG 1.5 times upper limit of normal), 6. Hemolytic anaemia -Sickle cell disease or thalassemia 7. Patients with Grade III ascites /complicated ascites 8. Patients with large spleen (size ≥ 15cm) 9. Recent variceal bleeding in less than 42 days 10. Patients with any focus of sepsis as proven by culture positivity or presence of spontaneous Bacterial Peritonitis (SBP) 11. H/o Seizures 12. Hepatocellular Carcinoma (HCC) or other malignancy 13. Acute Kidney Injury (AKI) with serum Creatinine \>1.5 mg/ dl, 14. Multi-organ failure, 15. Hepatic Encephalopathy or prior history of HE in less than 6months 16. HIV seropositivity, 17. Uncontrolled essential hypertension, CAD /Stroke 18. Massive hydrothorax 19. Pregnancy 20. Viral etiology of liver disease 21. Chronic kidney disease 22. Portal vein thrombosis 23. Planned for LT 24. Bone marrow hematopoietic stem cells \< 0.4

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Conditions

The condition(s) this trial relates to.

chronic liver failure cirrhosis of liver

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Decompensated liver cirrhosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institute of Liver & Biliary Sciences (ILBS)

    RECRUITING

    New Delhi, National Capital Territory of Delhi, 110070, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.