Clinical trials: in Iran
Skin Aging
Evaluation of Effectiveness and Safety of Stabilized Injectable Hyaluronic Acid (Perleux Body, Produced by Espad Pharmed Company) in the Neck Area
This study aimed to evaluate the safety and effectiveness of stabilized Hyaluronic Acid Injection under the brand name Perleux body for neck skin rejuvenation, elasticity improvement, and hydration enhancement.
- Trial name
- NCT06844760
- Testing
- Hyaluronic Acid (HA)
- Where
- Iran
- Volunteers
- 30 people
- Sponsor
- Espad Pharmed
Mucopolysaccharidosis Type 1
Efficacy and Safety of YW17 (Laronidase-CinnaGen) Compared to Aldurazyme® in MPS I Patients
The purpose of this phase III study is to assess the efficacy and safety of YW17 produced by CinnaGen Company compared to Aldurazyme® in mucopolysaccharidosis type I (MPS I) patients.
- Trial name
- NCT06406153
- Testing
- Laronidase, Antihistamine, Antipyretic
- Where
- 4 sites in Iran
- Volunteers
- 12 people
- Sponsor
- Cinnagen
HER2-positive Breast Cancer
Comparing Efficacy and Safety Between Pertuzumab® and Perjeta® in Neoadjuvant Treatment of HER2+ Breast Cancer
This study was a phase III, multicenter, triple-blind, equivalency clinical trial to determine the therapeutic efficacy and safety between Pertuzumab® (CinnaGen Co.) compared to originator pertuzumab in HER2-positive early breast…
- Trial name
- NCT04957212
- Testing
- Trastuzumab, Pertuzumab, Carboplatin
- Where
- 44 sites in Iran
- Volunteers
- 214 people
- Sponsor
- Cinnagen
Malignant Neoplasm of Breast
Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Trastuzumab (AryoTrust) Versus Herceptin® in Breast Cancer
This is A Phase III, randomized, two-armed, patient-outcome assessor-data analyzer blinded, parallel active controlled non-Inferiority clinical trial study to evaluate efficacy and safety of AryoTrust (Aryogen Trastuzumab in…
- Trial name
- NCT03425656
- Testing
- Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
- Where
- 19 sites in Iran
- Volunteers
- 108 people
- Sponsor
- AryoGen Pharmed Co.
Severe Hemophilia A
rFVIII-Fc (Produced by AryoGen Pharmed Co.) Pharmacokinetic Study
The study is designed as a randomized, two-armed, double-blind, single-dose, crossover, two-sequence, active-controlled, multi-center, bioequivalence clinical trial with a primary endpoint of dose-normalized area under the curve…
- Trial name
- NCT06137092
- Testing
- Factor VIII, recombinant human with Fc fusion (rFVIII-Fc)
- Where
- 5 sites in Iran
- Volunteers
- 50 people
- Sponsor
- AryoGen Pharmed Co.
Breast Cancer
AryoTrust® (Trastuzumab) Safety Study
This study was a phase IV, observational, multicenter, single-arm, open-label, post-marketing surveillance study for the assessment of AryoTrust safety in Iranian HER2-positive breast cancer patients undergoing adjuvant…
- Trial name
- NCT06021379
- Testing
- Trastuzumab
- Where
- 15 sites in Iran
- Volunteers
- 597 people
- Sponsor
- AryoGen Pharmed Co.
COVID-19
Immunogenicity and Safety of a Booster Dose of the SpikoGen Vaccine in Kidney Transplant Recipients After Two Doses of Sinopharm Vaccine
This is an open-label, single-arm clinical trial designed to evaluate the immunogenicity and safety of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) produced by CinnaGen Co.
- Trial name
- NCT05285384
- Testing
- SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
- Where
- Iran
- Volunteers
- 43 people
- Sponsor
- Cinnagen
Allergic Asthma, Uncontrolled Moderate to Severe
Efficacy and Safety of Zerafil® (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma
The purpose of this study is to evaluate the efficacy and safety of Omalizumab produced by CinnaGen compared with Xolair® (Genentech, Inc., USA And Novartis Pharmaceuticals Corp, Switzerland) in subjects with uncontrolled…
- Trial name
- NCT05813470
- Testing
- Omalizumab (CinnaGen), Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)
- Where
- 22 sites in Iran
- Volunteers
- 256 people
- Sponsor
- Cinnagen
Metastatic Colorectal Cancer
Comparing Efficacy and Safety of Cetuximab (CinnaGen) Versus Erbitux® (Merck) in Metastatic Colorectal Cancer
The study is designed as phase III, randomized, two armed, parallel, double blind (patient and assessor blinded), active controlled, and equivalency clinical trial with primary endpoint of Progression-Free Survival of Cetuximab®…
- Trial name
- NCT03391934
- Testing
- Cetuximab + FOLFIRI
- Where
- Iran
- Volunteers
- 234 people
- Sponsor
- Cinnagen
Age-Related Macular Degeneration, Neovascular Age-related Macular Degeneration
Efficacy and Safety of Aflibercept in Patients With Neovascular Age-related Macular Degeneration
The purpose of this study is to evaluate the efficacy and safety of Aflibercept (produced by CinnaGen Co, Iran) compared with Eylea® (Regeneron, USA) in subjects with Neovascular Age-related Macular Degeneration (nAMD).
- Trial name
- NCT05587062
- Testing
- Aflibercept (CinnaGen Co, Iran), Aflibercept (Regeneron, USA)
- Where
- Iran
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Cinnagen
Multiple Sclerosis, Relapsing-Remitting
Efficacy and Safety of Xacrel® (Ocrelizumab) in Participants With Relapsing Remitting Multiple Sclerosis
The purpose of this study is to evaluate the efficacy and safety of Ocrelizumab produced by CinnaGen compared with Ocrevus® (Roche, Switzerland) in subjects with relapsing remitting multiple sclerosis (RRMS).
- Trial name
- NCT04966338
- Testing
- Ocrelizumab (CinnaGen, Iran), Ocrelizumab (Roche, Switzerland)
- Where
- 15 sites in Iran
- Volunteers
- 170 people
- Sponsor
- Cinnagen
Relapsing Remitting Multiple Sclerosis (RRMS)
Efficacy and Safety of Peginterferon Beta-1a (CinnaGen) in Participants With Relapsing Remitting Multiple Sclerosis
The purpose of this study is to evaluate the efficacy and safety of peginterferon beta-1a produced by CinnaGen compared with CinnoVex® (CinnaGen) in subjects with relapsing remitting multiple sclerosis (RRMS).
- Trial name
- NCT05242133
- Testing
- Pegylated interferon beta-1a, Interferon Beta-1A Prefilled Syringe
- Where
- Iran
- Volunteers
- 168 people
- Sponsor
- Cinnagen
COVID-19
Immunogenicity and Safety of the SpikoGen COVID-19 Vaccine in Children Aged 5 to <12 Years and 12 to <18 Years Compared With Adults Aged 18 to 40 Years
This was a non-randomized, three-armed, open-label, parallel-group, non-inferiority trial designed to compare the immunogenicity and safety of the SpikoGen COVID-19 vaccine in children aged 5 to <12 years and 12 to <18 years with…
- Trial name
- NCT05231590
- Testing
- Low-dose SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant, SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
- Where
- Iran
- Volunteers
- 581 people, healthy volunteers welcome
- Sponsor
- Cinnagen
COVID-19
Immunogenicity and Safety of a Booster Dose of the SpikoGen COVID-19 Vaccine
This was a randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the safety and immunogenicity of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen)…
- Trial name
- NCT05175625
- Testing
- SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
- Where
- Iran
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Cinnagen
Covid19
Phase III Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)
This is a phase III, randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of a candidate adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen)…
- Trial name
- NCT05005559
- Testing
- SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
- Where
- Iran
- Volunteers
- 16,876 people, healthy volunteers welcome
- Sponsor
- Cinnagen
Covid19
Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)
This is a phase II, randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, and immunogenicity of a candidate adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit…
- Trial name
- NCT04944368
- Testing
- SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
- Where
- Iran
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Cinnagen
Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
Study on the Dose-response Relationship of Pharmacodynamic Parameters in Patients With Hemophilia With Inhibitors
Randomized, double-blind, single-dose, 5 ways crossover, exploratory clinical trial evaluating four different doses of AryoSeven (eptacog alfa, activated) and NovoSeven on selected pharmacodynamic parameters in patients with…
- Trial name
- NCT04789954
- Testing
- Eptacog alfa, activated
- Where
- Iran
- Volunteers
- 14 people
- Sponsor
- AryoGen Pharmed Co.
Relapsing Multiple Sclerosis (RMS)
Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)
This is an open label, non randomized, uncontrolled, multicenter, single arm observational study. In this study, the enrolled subjects will be treated with Rebif human serum albumin (HSA)-free formulation (with or without…
- Trial name
- NCT02921035
- Testing
- Rebif (Interferon beta-1a)
- Where
- 41 sites in Algeria, Argentina and 11 more
- Volunteers
- 594 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
Prospective, Non-interventional Study to Evaluate Immunogenicity of AryoSeven
This study evaluates the immunogenicity of the biosimilar rFVIIa (AryoSeven) in subjects receiving AryoSeven in real-life clinical practice.
- Conditions
- Hemophilia A With Inhibitor, Hemophilia B With Inhibitor, Factor VII Deficiency, Glanzmann's Thrombasthenia
- Trial name
- NCT03372993
- Where
- 2 sites in Iran
- Volunteers
- 200 people
- Sponsor
- AryoGen Pharmed Co.
COVID-19 Pneumonia
COVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores
This is a study trial to assess the effectiveness of the immune response stimulated by the genetically engineered Bacillus subtilis which express and display Spike protein of the SARS-COV2 on the spore coat.
- Trial name
- NCT05239923
- Testing
- Bacillus subtilis
- Where
- 2 sites in Hong Kong, Iran
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- DreamTec Research Limited