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A single center, one-arm, and open clinical study of PKA agonist (aminophylline) with conventional treatment for chronic or refractory primary immune thrombocytopenia

A single center, one-arm, and open clinical study of PKA agonist (aminophylline) with conventional treatment for chronic or refractory primary immune thrombocytopenia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-17013230
Enrollment
Unknown
Registered
2017-11-03
Start date
2017-05-20
Completion date
Unknown
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary immune thrombocytopenia

Interventions

Case series:PKA agonist (aminophylline) treats chronic or refractory primary immune thrombocytopenia

Sponsors

Department of Hematology, The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
11 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged between 11 to 65 years male and female; 2. The clinical diagnosis is refractory or chronic ITP patients which need treatment (platelet count < 30 x 10^9/L); 3. Patients are dependent on or not response to glucocorticoids; Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) at least 3 months and the platelet is not increasing in the last 4 weeks; 4. Understand the research program and voluntarily signed informed consent. ;Inclusion criteria: 1. Patients aged between 11 to 65 years male and female; 2. The clinical diagnosis is refractory or chronic ITP patients which need treatment (platelet count < 30 x 10^9/L); 3. Patients are dependent on or not response to glucocorticoids; Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) at least 3 months and the platelet is not increasing in the last 4 weeks; 4. Understand the research program and voluntarily signed informed consent. ;Inclusion criteria: 1. Patients aged between 11 to 65 years male and female; 2. The clinical diagnosis is refractory or chronic ITP patients which need treatment (platelet count < 30 x 10^9/L); 3. Patients are dependent on or not response to glucocorticoids; Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) at least 3 months and the platelet is not increasing in the last 4 weeks; 4. Understand the research program and voluntarily signed informed consent. ;Inclusion criteria: 1. Patients aged between 11 to 65 years male and female; 2. The clinical diagnosis is refractory or chronic ITP patients which need treatment (platelet count < 30 x 10^9/L); 3. Patients are dependent on or not response to glucocorticoids; Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) at least 3 months and the platelet is not increasing in the last 4 weeks; 4. Understand the research program and voluntarily signed informed consent. ;Inclusion criteria: 1. Patients aged between 11 to 65 years male and female; 2. The clinical diagnosis is refractory or chronic ITP patients which need treatment (platelet count < 30 x 10^9/L); 3. Patients are dependent on or not response to glucocorticoids; Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) at least 3 months and the platelet is not increasing in the last 4 weeks; 4. Understand the research program and voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients participated in other clinical trials in one month; 2. Pregnancy or breastfeeding women; 3. Megakaryophthisis; 4. The following biochemical indexes: ALT/AST is greater than 1.5 times the normal limit, total bilirubin, serum creatinine and alkaline phosphatase 1.2 times greater than normal; 5. Patients received with mabthera and splenectomy treatment in six monthes; 6. HIV infection, positive hepatitis C antibody or positive hepatitis B surface antigen; 7. Patients with arrhythmia; 8. Poor control of hypertension or active digestive tract ulcer; 9. Uncontrolled convulsive disease or mental illness; 10. Allergic to aminophylline; 11. Receiving the medicine of rofluorist.;Exclusion criteria: 1. Patients participated in other clinical trials in one month; 2. Pregnancy or breastfeeding women; 3. Megakaryophthisis; 4. The following biochemical indexes: ALT/AST is greater than 1.5 times the normal limit, total bilirubin, serum creatinine and alkaline phosphatase 1.2 times greater than normal; 5. Patients received with mabthera and splenectomy treatment in six monthes; 6. HIV infection, positive hepatitis C antibody or positive hepatitis B surface antigen; 7. Patients with arrhythmia; 8. Poor control of hypertension or active digestive tract ulcer; 9. Uncontrolled convulsive disease or mental illness; 10. Allergic to aminophylline; 11. Receiving the medicine of rofluorist.;Exclusion criteria: 1. Patients participated in other clinical trials in one month; 2. Pregnancy or breastfeeding women; 3. Megakaryophthisis; 4. The following biochemical indexes: ALT/AST is greater than 1.5 times the normal limit, total bilirubin, serum creatinine and alkaline phosphatase 1.2 times greater than normal; 5. Patients received with mabthera and splenectomy treatment in six monthes; 6. HIV infection, positive hepatitis C antibody or positive hepatitis B surface antigen; 7. Patients with arrhythmia; 8. Poor control of hypertension or active digestive tract ulcer; 9. Uncontrolled convulsive disease or mental illness; 10. Allergic to aminophylline; 11. Receiving the medicine of rofluorist.;Exclusion criteria: 1. Patients participated in other clinical trials in one month; 2. Pregnancy or breastfeeding women; 3. Megakaryophthisis; 4. The following biochemical indexes: ALT/AST is greater than 1.5 times the normal limit, total bilirubin, serum creatinine and alkaline phosphatase 1.2 times greater than normal; 5. Patients received with mabthera and splenectomy treatment in six monthes; 6. HIV infection, positive hepatitis C antibody or positive hepatitis B surface antigen; 7. Patients with arrhythmia; 8. Poor control of hypertension or active digestive tract ulcer; 9. Uncontrolled convulsive disease or mental illness; 10. Allergic to aminophylline; 11. Receiving the medicine of rofluorist.;Exclusion criteria: 1. Patients participated in other clinical trials in one month; 2. Pregnancy or breastfeeding women; 3. Megakaryophthisis; 4. The following biochemical indexes: ALT/AST is greater than 1.5 times the normal limit, total bilirubin, serum creatinine and alkaline phosphatase 1.2 times greater than normal; 5. Patients received with mabthera and splenectomy treatment in six monthes; 6. HIV infection, positive hepatitis C antibody or positive hepatitis B surface antigen; 7. Patients with arrhythmia; 8. Poor control of hypertension or active digestive tract ulcer; 9. Uncontrolled convulsive disease or mental illness; 10. Allergic to aminophylline; 11. Receiving the medicine of rofluorist.

Design outcomes

Primary

MeasureTime frame
the effectiveness;

Secondary

MeasureTime frame
safety;

Countries

China

Contacts

Public ContactKesheng Dai;Kesheng Dai;Kesheng Dai;Kesheng Dai;Kesheng Dai ;;;;

The First Affiliated Hospital of Soochow University;The First Affiliated Hospital of Soochow University;The First Affiliated Hospital of Soochow University;The First Affiliated Hospital of Soochow University;The First Affiliated Hospital of Soochow University

kdai@suda.edu.cn;kdai@suda.edu.cn;kdai@suda.edu.cn;kdai@suda.edu.cn;kdai@suda.edu.cn+86 18662272437;+86 18662272437;+86 18662272437;+86 18662272437;+86 18662272437

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026