A Phase 3 interventional study of DRL_RI (Proposed rituximab biosimilar) and MabThera® in Follicular Lymphoma, sponsored by Dr. Reddy's Laboratories Limited. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-22.
Sponsored by Dr. Reddy's Laboratories Limited · Phase 3, Interventional, and Treatment
The primary objective of the current study is to demonstrate the equivalent efficacy of rituximab (DRL_RI) and MabThera® in subjects with Low Tumor Burden Follicular Lymphoma (LTB-FL).
Also evaluated by Pharmacokinetic, safety, and immunogenicity assessment between a proposed biosimilar (DRL_RI) and the RMP, as an component of clinical study program, and collectively providing the evidence of biosimilarity.
The study will compare the safety and efficacy of DRL_RI vs MabThera in patients with Low Tumor Burden Follicular Lymphoma (LTB-FL). The primary objective is to establish comparative efficacy as measured by ORR up to week 28
It is planned to randomise approx. 312 subjects at approximately ≥ 130 study sites worldwide. Subjects with LTB-FL will be randomized to receive either DRL_RI or MabThera®. Till date, 68 patients have been randomized for the study.
The study specific objectives are mentioned below:
Primary Objective:
Secondary Objectives:
Exploratory Objectives
1,891 studies on the registry are indexed under Lymphoma, Follicular; 290 are open to participants now.
This study's enrollment of 317 is above the median of 48 across 1,503 interventional studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →Dr. Reddy's Laboratories Limited is the lead sponsor of 224 studies on the registry; 2 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject has at least 1 measurable tumor mass in 2 dimensions, and the mass must be:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DRL_RI (rituximab-Dr. Reddy's Lab) for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36
Biological: DRL_RI (Proposed rituximab biosimilar)
MabThera® for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Week 12, 20, 28 and 36.
Other: MabThera®
Proposed rituximab biosimilar, 100mg and 500mg, concentrate for solution for infusion
Reference product rituximab, 100mg and 500mg, concentrate for solution for infusion
Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma
Best Overall Response Rate (BORR) is defined as the proportion of participants in each treatment group that achieved a best overall response of either Complete response (CR), unconfirmed Complete response (CRu) or Partial response (PR), up to Month 7 (Week 28) based on central radiology review in accordance with the Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (CRu): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+CRu+PR.
Time frame: Month 7 (Week 28)
Overall Response Rate (ORR)
The overall response rate (ORR) is defined as proportion of participants in each treatment group achieved a complete response or partial response at week 12 and week 28 based on central radiology review in accordance with published response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (uCR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+uCR+PR.
Time frame: Week 12, Week 28
Complete Response Rate
Complete Response rate is defined as the proportion of participants in each treatment group who achieved complete response up to particular visit based on investigator assessment in accordance with the response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization.
Time frame: Week 28
Complete Response Rate as a Best Response
Complete Response Rate as a Best Response is defined as the proportion of participants in each treatment group that achieved the best complete response up to Week 28 based on central radiology review in accordance with the Cheson 1999, response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization.
Time frame: Week 28
Duration of Response (DOR)
Duration of response (DOR) defined as the time from date of the first documentation of tumor response (Complete Response, unconfirmed complete response or partial response) to the date of first documentation of progressive disease (PD) or to death due to any cause up to 52 weeks/ End of study (EOS). Progression is defined as per Cheson 1999, response criteria is: Target Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD. Target Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD. Also, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (longest diameter \[LDi\] 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease.
Time frame: Week 52
Progression-free Survival (PFS)
Progression-free survival (PFS) is defined as the time from date of randomization to the date of documented progressive disease or death due to any cause. Progression is defined as per Cheson 1999, response criteria is: Target Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD. Target Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD. Also, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (LDi 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease.
Time frame: Week 52
Overall Survival (OS)
The Overall survival (OS) defined as the time from date of randomization to the date of death from any cause up to 52 weeks or EOS.
Time frame: Week 52
Number of Participants With Adverse Events
The safety and tolerability of DRL_RI and MabThera® in participants with CD20-positive, LTB-FL was evaluated.
Time frame: From Screening (Day -28 to -1) up to 52 weeks
Number of Participants With Positive Anti-drug Antibody (ADA)
The immunogenicity of the Proposed Rituximab Biosimilar (DRL_RI) with MabThera® among trial participants was compared.
Time frame: On Day 1, Week 2, Week 3, Week 4, Week 12 post dose
The trial was conducted at 4 sites in the United States from 15 May 2019 to 27 February 2023. The final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome on 28 September 2022.
| Milestone | Arm A: DRL_RI | Arm B: MabThera® |
|---|---|---|
| Started | 162 | 155 |
| Completed | 143 | 129 |
| Not completed | 19 | 26 |
| Withdrew: Withdrawal by subject | 4 | 4 |
| Withdrew: Adverse event | 2 | 4 |
| Withdrew: Not related to covid-19 | 9 | 13 |
| Withdrew: Lost to follow-up | 0 | 2 |
| Withdrew: Death | 3 | 2 |
| Withdrew: Physician decision | 1 | 1 |
Best Overall Response Rate (BORR) is defined as the proportion of participants in each treatment group that achieved a best overall response of either Complete response (CR), unconfirmed Complete response (CRu) or Partial response (PR), up to Month 7 (Week 28) based on central radiology review in accordance with the Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (CRu): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+CRu+PR.
| percentage of participants | Arm A: DRL_RI | Arm B: MabThera® |
|---|---|---|
| Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma | 80.2 (73.3 to 86.1) | 79.4 (72.1 to 85.4) |
The overall response rate (ORR) is defined as proportion of participants in each treatment group achieved a complete response or partial response at week 12 and week 28 based on central radiology review in accordance with published response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (uCR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+uCR+PR.
| percentage of particpants | Arm A: DRL_RI | Arm B: MabThera® |
|---|---|---|
| Week 12 | 62.3 (54.4 to 69.8) | 63.9 (55.8 to 71.4) |
| Week 28 | 75.3 (67.9 to 81.7) | 73.5 (65.9 to 80.3) |
Complete Response rate is defined as the proportion of participants in each treatment group who achieved complete response up to particular visit based on investigator assessment in accordance with the response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization.
| percentage of participants | Arm A: DRL_RI | Arm B: MabThera® |
|---|---|---|
| Complete Response Rate | 32.7 (25.6 to 40.5) | 34.2 (26.8 to 42.2) |
Complete Response Rate as a Best Response is defined as the proportion of participants in each treatment group that achieved the best complete response up to Week 28 based on central radiology review in accordance with the Cheson 1999, response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization.
| percentage of participants | Arm A: DRL_RI | Arm B: MabThera® |
|---|---|---|
| Complete Response Rate as a Best Response | 34.0 (26.7 to 41.8) | 35.5 (28.0 to 43.6) |
Duration of response (DOR) defined as the time from date of the first documentation of tumor response (Complete Response, unconfirmed complete response or partial response) to the date of first documentation of progressive disease (PD) or to death due to any cause up to 52 weeks/ End of study (EOS). Progression is defined as per Cheson 1999, response criteria is: Target Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD. Target Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD. Also, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (longest diameter \[LDi\] 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease.
| Weeks | Arm A: DRL_RI | Arm B: MabThera® |
|---|---|---|
| Duration of Response (DOR) | NA (NA to NA) | NA (NA to NA) |
Progression-free survival (PFS) is defined as the time from date of randomization to the date of documented progressive disease or death due to any cause. Progression is defined as per Cheson 1999, response criteria is: Target Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD. Target Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD. Also, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (LDi 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease.
| Weeks | Arm A: DRL_RI | Arm B: MabThera® |
|---|---|---|
| Progression-free Survival (PFS) | NA (NA to NA) | NA (NA to NA) |
The Overall survival (OS) defined as the time from date of randomization to the date of death from any cause up to 52 weeks or EOS.
| Weeks | Arm A: DRL_RI | Arm B: MabThera® |
|---|---|---|
| Overall Survival (OS) | NA (NA to NA) | NA (NA to NA) |
The safety and tolerability of DRL_RI and MabThera® in participants with CD20-positive, LTB-FL was evaluated.
| Participants | Arm A: DRL_RI | Arm B: MabThera® |
|---|---|---|
| Treatment-emergent adverse events (TEAEs) | 113 | 103 |
| Non-TEAEs | 13 | 18 |
| Infusion related AEs | 28 | 32 |
| TEAE>=Common terminology Criteria for Adverse events (CTCAE) grade 3 | 30 | 24 |
| Serious TEAEs | 22 | 21 |
| TEAEs related to study drug | 48 | 50 |
| Fatal TEAEs | 3 | 2 |
The immunogenicity of the Proposed Rituximab Biosimilar (DRL_RI) with MabThera® among trial participants was compared.
| Participants | Arm A: DRL_RI | Arm B: MabThera® |
|---|---|---|
| Day 1 | 2 | 0 |
| Week 2 | 2 | 0 |
| Week 3 | 1 | 0 |
| Week 4 | 2 | 0 |
| Week 12 | 2 | 0 |
Collected over From Screening (Day -28 to -1) up to 52 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: DRL_RI | 3/162 (1.9%) | 22/162 (13.6%) | 47/162 (29%) |
| Arm B: MabThera® | 2/153 (1.3%) | 21/153 (13.7%) | 49/153 (32%) |
| Event | Arm A: DRL_RI | Arm B: MabThera® |
|---|---|---|
| COVID-19 pneumoniaInfections and infestations | 10/162 | 5/153 |
| COVID-19Infections and infestations | 3/162 | 4/153 |
| Cholecystitis acuteHepatobiliary disorders | 0/162 | 1/153 |
| Atrial fibrillationCardiac disorders | 0/162 | 1/153 |
| IleusGastrointestinal disorders | 0/162 | 1/153 |
| Lumbar herniaGastrointestinal disorders | 0/162 | 1/153 |
| Anal abscessInfections and infestations | 1/162 | 1/153 |
| DiverticulitisInfections and infestations | 0/162 | 1/153 |
| GastroenteritisInfections and infestations | 0/162 | 1/153 |
| InfectionInfections and infestations | 0/162 | 1/153 |
| Event | Arm A: DRL_RI | Arm B: MabThera® |
|---|---|---|
| COVID-19Infections and infestations | 19/162 | 17/153 |
| NeutropeniaBlood and lymphatic system disorders | 13/162 | 2/153 |
| PruritusSkin and subcutaneous tissue disorders | 11/162 | 10/153 |
| NauseaGastrointestinal disorders | 6/162 | 10/153 |
| PyrexiaGeneral disorders | 1/162 | 10/153 |
| Abdominal painGastrointestinal disorders | 3/162 | 8/153 |
The Intent to Treat (ITT) Analysis Set included all randomized participants.
| Age, Continuous(Years) | Arm A: DRL_RI | Arm B: MabThera® | Total |
|---|---|---|---|
| Mean | 57.6 ± 12.37 | 55.8 ± 13.03 | 56.7 ± 12.70 |
| Sex: Female, Male(Participants) | Arm A: DRL_RI | Arm B: MabThera® | Total |
|---|---|---|---|
| Female | 82 | 78 | 160 |
| Male | 80 | 77 | 157 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: DRL_RI | Arm B: MabThera® | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 44 | 45 | 89 |
| Unknown or Not Reported | 118 | 110 | 228 |
| Race/Ethnicity, Customized(Participants) | Arm A: DRL_RI | Arm B: MabThera® | Total |
|---|---|---|---|
| White | 104 | 107 | 211 |
| Asian | 51 | 46 | 97 |
| Black or African American | 0 | 0 | 0 |
| Aboriginal/Torres Strait Islander | 1 | 0 | 1 |
| Unknown | 1 | 1 | 2 |
| Not Reported | 5 | 1 | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2019 to primary completion in Sep 2022, 40 months.
Results were first posted in Jan 2024, 1 year 3 months after primary completion.
Of 45 industry-sponsored phase 3 interventional studies under Lymphoma, Follicular, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 86. This study's 40 months is below that.
Counting every sponsor, half of 80 studies reached it within 63 months; a quarter within 36 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Dr. Reddy's Laboratories Limited →