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Immunosuppressant

Cyclosporin A for Primary Biliary Cirrhosis

Phase 4
Waitlist Available
Research Sponsored by West China Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved
All Individual Drugs Already Approved
Approved for 20 Other Conditions

Summary

Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by mycophenolate mofetil versus cyclosporin A

Eligible Conditions
  • Primary Biliary Cirrhosis
  • Autoimmune Hepatitis
  • Immunosuppression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Biochemical remission
Secondary study objectives
Changes in liver stiffness
Minimal response
Partial remission
+2 more

Side effects data

From 2014 Phase 3 trial • 595 Patients • NCT00114777
56%
Diarrhoea
53%
Anaemia
50%
Oedema peripheral
43%
Urinary tract infection
35%
Transplant dysfunction
34%
Hypertension
33%
Constipation
30%
Pyrexia
29%
Cough
29%
Nausea
28%
Leukopenia
26%
Hypokalaemia
24%
Nasopharyngitis
23%
Hyperkalaemia
22%
Back pain
22%
Proteinuria
22%
Haematuria
21%
Hypotension
20%
Headache
20%
Vomiting
20%
Bronchitis
20%
Procedural pain
20%
Insomnia
19%
Upper respiratory tract infection
19%
Pain in extremity
19%
Hypocalcaemia
19%
Hyperglycaemia
19%
Hypophosphataemia
18%
Dyspnoea
18%
Dyslipidaemia
18%
Arthralgia
16%
Abdominal pain
16%
Blood creatinine increased
15%
Anxiety
14%
Dysuria
14%
Fatigue
14%
Oedema
14%
Incision site pain
14%
Dizziness
13%
Thrombocytopenia
13%
Asthenia
13%
Hypercalcaemia
12%
Cytomegalovirus infection
12%
Dyspepsia
12%
Chest pain
11%
Hypercholesterolaemia
11%
Hypomagnesaemia
11%
Herpes zoster
11%
Abdominal pain upper
11%
Cataract
10%
Skin lesion
10%
Sinusitis
9%
Pruritus
9%
Hyperphosphataemia
9%
Influenza
9%
Atrial fibrillation
9%
Weight decreased
9%
Muscle spasms
9%
Hyperuricaemia
9%
Haematoma
9%
Tremor
9%
Fall
9%
Acidosis
9%
Renal tubular necrosis
9%
Haemorrhoids
9%
Oropharyngeal pain
8%
Tachycardia
8%
Diabetes mellitus
8%
Metabolic acidosis
8%
Pneumonia
8%
Chronic allograft nephropathy
8%
Conjunctivitis
8%
Leukocytosis
8%
Weight increased
8%
Hyponatraemia
8%
Dyspnoea exertional
8%
Onychomycosis
8%
Oral candidiasis
8%
Decreased appetite
7%
Ecchymosis
7%
Osteoporosis
7%
Renal impairment
7%
Pain
7%
Abdominal distension
7%
Leukocyturia
7%
Erectile dysfunction
7%
Pyelonephritis
7%
Musculoskeletal pain
7%
Dehydration
7%
Oral herpes
7%
C-reactive protein increased
7%
Hyperlipidaemia
7%
Neutropenia
6%
Myalgia
6%
Skin papilloma
6%
Paraesthesia
6%
Fluid overload
6%
Rhinitis
5%
Productive cough
5%
Hydronephrosis
5%
Escherichia urinary tract infection
5%
Cardiac failure congestive
5%
Aphthous stomatitis
5%
Hypoglycaemia
5%
Bradycardia
5%
Complications of transplanted kidney
5%
Lymphocele
5%
Lymphopenia
5%
Chills
5%
Basal cell carcinoma
5%
Peripheral swelling
5%
Gastrooesophageal reflux disease
5%
Osteopenia
4%
Sinus bradycardia
4%
Deep vein thrombosis
4%
Gastroenteritis
4%
Acne
4%
Renal failure acute
4%
Ligament sprain
4%
Sciatica
4%
Squamous cell carcinoma of skin
4%
Myocardial infarction
4%
Sepsis
4%
Contusion
4%
Gastritis
4%
Hyperparathyroidism
4%
Hyperkeratosis
4%
Depression
4%
Blood pressure increased
4%
Fungal skin infection
3%
Urinary retention
3%
Left ventricular hypertrophy
3%
Neck pain
3%
Nasal congestion
3%
Angina pectoris
3%
Renal vein thrombosis
3%
Urosepsis
3%
Cellulitis
3%
Respiratory tract infection
3%
Flatulence
3%
Cushingoid
3%
Cerebrovascular accident
3%
Vertigo
2%
Wound dehiscence
2%
Transient ischaemic attack
2%
Wound complication
2%
Pyelonephritis acute
2%
Abscess
2%
Squamous cell carcinoma
2%
Muscular weakness
2%
Osteomyelitis
2%
Ureteric stenosis
2%
Arteriosclerosis coronary artery
2%
Polyomavirus-associated nephropathy
2%
Arthritis
2%
Skin ulcer
2%
Bowen's disease
2%
Graft loss
2%
Sudden death
2%
Bacteraemia
2%
Graft complication
2%
Postoperative wound infection
2%
Polycythaemia
2%
Arteriovenous fistula thrombosis
2%
Gout
2%
Pulmonary oedema
2%
Pulmonary tuberculosis
2%
Cardiac failure
2%
Pneumocystis jirovecii pneumonia
2%
Gangrene
2%
Gastric ulcer
1%
Mycoplasma infection
1%
Post procedural urine leak
1%
Urinary tract infection bacterial
1%
Thrombosis
1%
Hypertensive crisis
1%
Mediastinal disorder
1%
Pneumonia cryptococcal
1%
Duodenitis
1%
Cytomegalovirus colitis
1%
Pleural effusion
1%
Cerebral ischaemia
1%
Acute pulmonary oedema
1%
Device related infection
1%
Necrotising fasciitis
1%
Renal haemorrhage
1%
Bladder prolapse
1%
Erosive oesophagitis
1%
Pseudomonal sepsis
1%
Peripheral artery stenosis
1%
Supraventricular tachyarrhythmia
1%
Confusional state
1%
Urinary incontinence
1%
Vesicoureteric reflux
1%
Cytomegalovirus hepatitis
1%
Shunt occlusion
1%
Anal abscess
1%
Cytomegalovirus syndrome
1%
Cytomegalovirus viraemia
1%
Diabetic bullosis
1%
Diabetic foot
1%
Cerebral haemorrhage
1%
Adverse drug reaction
1%
Hypercoagulation
1%
Wound evisceration
1%
Renal artery dissection
1%
Urinary tract infection enterococcal
1%
Diverticular perforation
1%
Venous thrombosis limb
1%
Ventricular extrasystoles
1%
Obstructive uropathy
1%
Respiratory distress
1%
Hypovolaemia
1%
Progressive multifocal leukoencephalopathy
1%
Chronic obstructive pulmonary disease
1%
Enterocolitis haemorrhagic
1%
Renal artery thrombosis
1%
Acute myocardial infarction
1%
Atrial flutter
1%
Ureteral necrosis
1%
Ischaemic cardiomyopathy
1%
Toxicity to various agents
1%
Septic shock
1%
Osteoarthritis
1%
Cryptococcosis
1%
Road traffic accident
1%
Vaginal haemorrhage
1%
Varicella
1%
Oral fungal infection
1%
Hyperparathyroidism tertiary
1%
Colon cancer metastatic
1%
Hepatic mass
1%
Phlebitis
1%
Small intestinal obstruction
1%
Gastroduodenal ulcer
1%
Arterial stenosis
1%
Escherichia sepsis
1%
Lower gastrointestinal haemorrhage
1%
Macular oedema
1%
Post procedural haematoma
1%
Haemorrhage
1%
Femur fracture
1%
Abdominal hernia
1%
Abdominal pain lower
1%
Abscess limb
1%
Benign prostatic hyperplasia
1%
Non-cardiac chest pain
1%
Oesophagitis
1%
Appendicitis
1%
Urinary tract obstruction
1%
Uveitis
1%
Urinary tract infection pseudomonal
1%
Acute respiratory distress syndrome
1%
Aortic valve stenosis
1%
Pancreatitis acute
1%
Aortic valve disease
1%
Clostridium difficile colitis
1%
Guillain-Barre syndrome
1%
Perinephric collection
1%
Tachyarrhythmia
1%
Coronary artery disease
1%
Joint tuberculosis
1%
Localised infection
1%
Postrenal failure
1%
Aspiration
1%
Intestinal obstruction
1%
Mobility decreased
1%
Tinea versicolour
1%
Fistula
1%
Ventricular tachycardia
1%
Tooth abscess
1%
Thrombophlebitis superficial
1%
Gastroenteritis viral
1%
Hepatitis
1%
Cardio-respiratory arrest
1%
Erysipelas
1%
Haemorrhage intracranial
1%
Kaposi's sarcoma
1%
Meningitis cryptococcal
1%
Ileus
1%
Incision site complication
1%
Lymphangitis
1%
Muscle rupture
1%
Rectal adenocarcinoma
1%
Synovitis
1%
Urinary fistula
1%
BK virus infection
1%
Cardiogenic shock
1%
Cerebral aspergillosis
1%
Cholangitis
1%
Chorioretinitis
1%
Diverticulum
1%
Hepatic cyst infection
1%
Hydrocele
1%
Hypercreatinaemia
1%
Intestinal perforation
1%
Leishmaniasis
1%
Lower respiratory tract infection
1%
Meniscus injury
1%
Metrorrhagia
1%
Oesophageal candidiasis
1%
Perirenal haematoma
1%
Pulmonary embolism
1%
Volvulus
1%
Adenocarcinoma
1%
Blood creatine increased
1%
Bronchopneumopathy
1%
Cardiac arrest
1%
Hypoxic-ischaemic encephalopathy
1%
Intestinal fistula
1%
Lung infection
1%
Neurotoxicity
1%
Osteonecrosis
1%
Overdose
1%
Post procedural complication
1%
Renal infarct
1%
Tendon rupture
1%
Asthma
1%
B-cell lymphoma
1%
Cerebral fungal infection
1%
Complications of transplant surgery
1%
Dysentery
1%
Emphysematous cystitis
1%
Epilepsy
1%
Gastric ulcer haemorrhage
1%
Intraductal proliferative breast lesion
1%
Lobar pneumonia
1%
Muscle haemorrhage
1%
Pancreatic carcinoma
1%
Perirectal abscess
1%
Post procedural haemorrhage
1%
Respiratory tract infection fungal
1%
Sinusitis bacterial
1%
Staphylococcal bacteraemia
1%
Suicide attempt
1%
Umbilical hernia
1%
Wound infection
1%
Bacterial pyelonephritis
1%
Convulsion
1%
Cytomegalovirus enteritis
1%
Diabetic gangrene
1%
Diverticulum intestinal haemorrhagic
1%
Dupuytren's contracture
1%
Electrolyte imbalance
1%
Haemoptysis
1%
Klebsiella infection
1%
Microalbuminuria
1%
Multi-organ failure
1%
Myocardial ischaemia
1%
Non-Hodgkin's lymphoma
1%
Pneumonia aspiration
1%
Pneumothorax
1%
Plasma cell myeloma
1%
Pneumonia bacterial
1%
Renal cell carcinoma
1%
Renal tubular disorder
1%
Vascular graft complication
1%
White blood cells urine positive
1%
Acute coronary syndrome
1%
Acute psychosis
1%
Arrhythmia
1%
Arrhythmia supraventricular
1%
Arteriovenous fistula aneurysm
1%
Central nervous system lymphoma
1%
Cholangiocarcinoma
1%
Cholangitis acute
1%
Colitis
1%
Cystitis bacterial
1%
Cytomegalovirus gastrointestinal infection
1%
Diverticulitis
1%
Encephalomyelitis
1%
Epididymitis
1%
Epiglottic carcinoma
1%
Helicobacter gastritis
1%
Hepatic cyst
1%
Hip fracture
1%
International normalised ratio increased
1%
Lung cancer metastatic
1%
Lung disorder
1%
Nephropathy
1%
Nephropathy toxic
1%
Partial seizures
1%
Prostatitis
1%
Scrotal oedema
1%
Duodenal ulcer
1%
Brain mass
1%
Extravasation
1%
Gallbladder perforation
1%
Graft thrombosis
1%
Oral disorder
1%
Pancreatitis
1%
Platelet count decreased
1%
Prerenal failure
1%
Prostate cancer
1%
Renal artery stenosis
1%
Respiratory arrest
1%
Shock
1%
Visual acuity reduced
1%
Prostatism
1%
Ureteric obstruction
1%
Post procedural discharge
1%
Hypertriglyceridaemia
1%
Mitral valve stenosis
1%
Ischaemic stroke
1%
Decubitus ulcer
1%
Peripheral arterial occlusive disease
1%
Bronchopneumonia
1%
Psoas abscess
1%
Ureteric fistula
1%
Staphylococcal sepsis
1%
Intestinal ischaemia
1%
Renal transplant failure
1%
Aspergillus infection
1%
Renal failure
1%
Adenocarcinoma of colon
1%
Agranulocytosis
1%
Pancytopenia
1%
Abscess rupture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept More Intensive (MI) Regimen
Belatacept Less Intensive (LI) Regimen
Cyclosporin (CsA)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cyclosporin AExperimental Treatment1 Intervention
Group II: Mycophenolate MofetilActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclosporine
FDA approved

Find a Location

Who is running the clinical trial?

West China HospitalLead Sponsor
563 Previous Clinical Trials
4,075,702 Total Patients Enrolled
~21 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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